| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B24210EXBUF550 | 10-EXBUF-55 | 10-EXBUF-55 | General purpose reagent used in preparation of samples for ALPCO stool-based bio General purpose reagent used in preparation of samples for ALPCO stool-based biomarker kits. | PPM | General Purpose Reagent | 1 | Extraction Buffer 4X, 55mL Fill |
| 2 | B24280CPTHUE100 | 80-CPTHU-E10 | 80-CPTHU-E10 | The ALPCO C-peptide ELISA Jumbo is designed for the quantitative determination o The ALPCO C-peptide ELISA Jumbo is designed for the quantitative determination of C-peptide in human serum and plasma. For in vitro diagnostic use. | JKD | Radioimmunoassay, C-Peptides Of Proinsulin | 1 | ALPCO C-peptide ELISA Jumbo |
| 3 | B24280CPTHUE010 | 80-CPTHU-E01.1 | 80-CPTHU-E01.1 | The ALPCO C-peptide ELISA is designed for the quantitative determination of C-pe The ALPCO C-peptide ELISA is designed for the quantitative determination of C-peptide in human serum and plasma. For in vitro diagnostic use. | JKD | Radioimmunoassay, C-Peptides Of Proinsulin | 1 | ALPCO C-peptide ELISA |
| 4 | B24225HCGHUE010 | 25-HCGHU-E01 | 25-HCGHU-E01 | The Human Chorionic Gonadotropin ELISA is intended for use in the quantitative d The Human Chorionic Gonadotropin ELISA is intended for use in the quantitative determination of human chorionic gonadotropin (hCG) concentration in human serum. The assay is for use in the early diagnosis of pregnancy in a clinical laboratory setting. | JHI | Visual, Pregnancy Hcg, Prescription Use | 2 | Human Chorionic Gonadotropin ELISA |
| 5 | B24221ACTHUE010 | 21-ACTHU-E01 | 21-ACTHU-E01 | The Adrenocorticotropic Hormone ELISA is intended for use in the quantitative de The Adrenocorticotropic Hormone ELISA is intended for use in the quantitative determination of ACTH (Adrenocorticotropic Hormone) in human EDTA plasma. | CKG | Radioimmunoassay, Acth | 2 | Adrenocorticotropic Hormone ELISA |
| 6 | B24235DSGHUE010 | 35-DSGHU-E01 | 35-DSGHU-E01 | Anti-ds-DNA-G ELISA is a solid phase enzyme immunoassay with human recombinant d Anti-ds-DNA-G ELISA is a solid phase enzyme immunoassay with human recombinant double-stranded DNA (dsDNA) for the quantitative and qualitative detection of IgG antibodies against dsDNA in human serum. Anti-dsDNA antibodies mainly recognize the phosphat units of the DNA, thus these autoantibodies also bind single stranded DNA (ssDNA). To ensure correct quantitation of anti-dsDNA antibodies the used antigen has been proven to be free of contamination with ssDNA. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE). | LSW | Anti-Dna Antibody, Antigen And Control | 2 | Anti-ds-DNA-G ELISA |
| 7 | B24235CAAHUE010 | 35-CAAHU-E01 | 35-CAAHU-E01 | The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highl The Anti-Cardiolipin-A ELISA is a solid phase enzyme immunoassay employing highly purified cardiolipin plus native human Beta-2-glycoprotein I (Beta-2-GPI) for the semiquantitative and qualitative detection of IgA antibodies against cardiolipin in human serum. Anti-cardiolipin antibodies mainly recognize specific epitopes on a complex composed of cardiolipin and Beta-2-GPI which are only expressed when Beta-2-GPI interacts with cardiolipin. The assay is an aid in the diagnosis of systemic lupus erythematosus (SLE), primary and secondary anti-phospholipid syndrome (APS) and should be used in conjunction with other serological tests and clinical findings. | MID | System, Test, Anticardiolipin Immunological | 2 | Anti-Cardiolipin-A ELISA |
| 8 | B24225TT4HUE010 | 25-TT4HU-E01 | 25-TT4HU-E01 | The Total Thyroxine ELISA (Total T4 ELISA) is intended for use in the quantitati The Total Thyroxine ELISA (Total T4 ELISA) is intended for use in the quantitative determination of total thyroxine (T4) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid disorders. | KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 2 | Total Thyroxine ELISA (Total T4 ELISA) |
| 9 | B24225TRIHUE010 | 25-TRIHU-E01 | 25-TRIHU-E01 | The Total Triiodothyronine T3 ELISA (Total T3 ELISA) is intended for use in the The Total Triiodothyronine T3 ELISA (Total T3 ELISA) is intended for use in the quantitative determination of triiodothyronine (T3) concentration in human serum. The test is useful in the diagnosis and treatment of thyroid diseases such as hyperthyroidism. | CDP | Radioimmunoassay, Total Triiodothyronine | 2 | Total Triiodothyronine T3 ELISA (Total T3 ELISA) |
| 10 | B24225IGEHUE010 | 25-IGEHU-E01 | 25-IGEHU-E01 | The Total IgE ELISA is intended for use in the quantitative determination of imm The Total IgE ELISA is intended for use in the quantitative determination of immunoglobulin E in human serum. The assay is to be used for the assessment of hypersensitive and allergic reactions in patients. | DGC | Ige, Antigen, Antiserum, Control | 2 | Total IgE ELISA |
| 11 | B24221IPTHUE010 | 21-IPTHU-E01 | 21-IPTHU-E01 | The PTH (Intact, 1-84) ELISA is intended for use in the quantitative determinati The PTH (Intact, 1-84) ELISA is intended for use in the quantitative determination of Intact-PTH (Parathyroid Hormone) in human serum. | CEW | Radioimmunoassay, Parathyroid Hormone | 2 | PTH (Intact, 1-84) ELISA |
| 12 | B24220ESTHUUE010 | 20-ESTHUU-E01 | 20-ESTHUU-E01 | The Estradiol Ultrasensitive ELISA is an enzyme immunoassay for the quantitative The Estradiol Ultrasensitive ELISA is an enzyme immunoassay for the quantitative measurement of Estradiol in serum and plasma. For In Vitro Diagnostic Use. | CHP | Radioimmunoassay, Estradiol | 1 | Ultrasensitive Estradiol ELISA |
| 13 | B2422017OHUE01SLV0 | 20-17OHU-E01-SLV | 20-17OHU-E01-SLV | An enzyme immunoassay for the quantitative in vitro diagnostic measurement of ac An enzyme immunoassay for the quantitative in vitro diagnostic measurement of active free 17-hydroxyprogesterone in saliva. Measurements of 17-hydroxyprogesterone are used as an aid in the diagnosis of various disorders of the adrenal glands or the ovaries, and as an aid in the diagnosis of late onset of 21-hydroxylase deficiency, a common cause of Congenital Adrenal Hyperplasia. This test is not intended for newborn screening. | JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 1 | 17-alpha Hydroxy Progesterone ELISA (Saliva) |
| 14 | B2422017OHUE010 | 20-17OHU-E01 | 20-17OHU-E01 | The 17-α-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in The 17-α-OH Progesterone ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-α-OH Progesterone (17-α-OHP) in serum or plasma (EDTA, heparin, or citrate). For in vitro diagnostic use. | JLX | Radioimmunoassay, 17-Hydroxyprogesterone | 1 | 17-alpha Hydroxy Progesterone ELISA |
| 15 | B24211PREHUE010 | 11-PREHU-E01 | 11-PREHU-E01 | Intended for the direct quantitative determination of Pregnenolone by enzyme imm Intended for the direct quantitative determination of Pregnenolone by enzyme immunoassay using human serum. For in vitro diagnostic use. | JNG | Radioimmunoassay, Pregnenolone | 1 | Pregnenolone ELISA |
| 16 | B24211DHEHUE010 | 11-DHEHU-E01 | 11-DHEHU-E01 | Intended for the direct quantitative determination of DHEA-S by enzyme immunoass Intended for the direct quantitative determination of DHEA-S by enzyme immunoassay in human serum. For in vitro diagnostic use. | JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | Dehydroepiandrosterone Sulfate (DHEA-S) ELISA |
| 17 | B24280INSHUCH100 | 80-INSHU-CH10 | 80-INSHU-CH10 | The ALPCO Insulin Chemiluminescence ELISA Jumbo is designed for the quantitative The ALPCO Insulin Chemiluminescence ELISA Jumbo is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic use. | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | STELLUX® Chemi Human Insulin ELISA Jumbo |
| 18 | B24243FETHUE010 | 43-FETHU-E01 | 43-FETHU-E01 | This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitat This ELISA (enzyme-linked immunosorbent assay) kit is intended for the quantitative determination of human Fetuin-A, also known as alpha-2-HS glycoprotein (AHSG), in serum, plasma (EDTA or Heparin), cell culture supernatant, tissue extracts and urine. The measurement of Fetuin-A in serum or plasma aids in the diagnosis of some cancers and genetically inherited deficiencies of this serum protein. This Fetuin-A ELISA kit is for in vitro diagnostic use. | DEF | Alpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control | 1 | Fetuin-A ELISA |
| 19 | B24238GLUHUR1000 | 38-GLUHU-R100 | 38-GLUHU-R100 | The Glucagon RIA is a radioimmunoassay for the quantitative measurement of gluca The Glucagon RIA is a radioimmunoassay for the quantitative measurement of glucagon in human plasma. | JME | Radioimmunoassay, Glucagon | 1 | Glucagon RIA |
| 20 | B24235E6PHUE010 | 35-E6PHU-E01 | 35-E6PHU-E01 | The ENA-6Pro ELISA is a solid phase enzyme immunoassay for the separate semiquan The ENA-6Pro ELISA is a solid phase enzyme immunoassay for the separate semiquantitative detection of IgG antibodies against six cellular and nuclear antigens in human serum. The wells are coated with recombinant SS-B, SS-A 52 kDa, Scl 70, Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings. | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | ENA-6Pro ELISA |
| 21 | B24235ANAHUE010 | 35-ANAHU-E01 | 35-ANAHU-E01 | The ANA-8Pro ELISA is a solid phase enzyme immunoassay for the separate qualitat The ANA-8Pro ELISA is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is an aid in the differential diagnosis of systemic rheumatic diseases and should be used in conjunction with other serological tests and clinical findings. | LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | ANA-8Pro ELISA |
| 22 | B24221EPOHUE010 | 21-EPOHU-E01 | 21-EPOHU-E01 | The EPO ELISA is intended for use in the quantitative determination of Erythropo The EPO ELISA is intended for use in the quantitative determination of Erythropoietin (EPO) in human serum. This assay is intended for in vitro diagnostic use, as an aid in the diagnosis of anemias and polycythemias. | GGT | Assay, Erythropoietin | 2 | Erythropoietin ELISA |
| 23 | B24220LHUHUE010 | 20-LHUHU-E01 | 20-LHUHU-E01 | The LH (Urine) ELISA is an enzyme immunoassay for the quantitative in vitro diag The LH (Urine) ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of LH in urine. For in vitro diagnostic use. | CEP | Radioimmunoassay, Luteinizing Hormone | 1 | Luteinizing Hormone ELISA (LH ELISA) (Urine) |
| 24 | B24211ESTHUE010 | 11-ESTHU-E01 | 11-ESTHU-E01 | Intended for the direct quantitative determination of Estradiol by enzyme immuno Intended for the direct quantitative determination of Estradiol by enzyme immunoassay in human serum. For in vitro diagnostic use. | CHP | Radioimmunoassay, Estradiol | 1 | Estradiol ELISA |
| 25 | B24280INSHUUE010 | 80-INSHUU-E01.1 | 80-INSHUU-E01.1 | The ALPCO Ultrasensitive Insulin ELISA is designed for the quantitative determin The ALPCO Ultrasensitive Insulin ELISA is designed for the quantitative determination of insulin in human serum and plasma. For in vitro diagnostic use. | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | ALPCO Ultrasensitive Insulin ELISA |
| 26 | B2423825DHUE010 | 38-25DHU-E01 | 38-25DHU-E01 | The 25OH Vitamin D Total ELISA Test is intended for the quantitative determinati The 25OH Vitamin D Total ELISA Test is intended for the quantitative determination of 25-hydroxyvitamin D2 and D3 (25-OH D2 and 25-OH D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient. | MRG | System, Test, Vitamin D | 2 | 25OH Vitamin D Total ELISA |
| 27 | B24230EZEX1000 | 30-EZEX-100 | 30-EZEX-100 | The ALPCO Easy Stool Extraction Device is intended for the storage and preparati The ALPCO Easy Stool Extraction Device is intended for the storage and preparation of human stool samples for examination. For In Vitro Diagnostic Use. | NNK | Container, Specimen Mailer And Storage, Non-Sterile | 1 | Easy Stool Extraction Device |
| 28 | B24225BMGHUE010 | 25-BMGHU-E01 | 25-BMGHU-E01 | The Beta-2 Microglobulin ELISA is intended for use in the quantitative determina The Beta-2 Microglobulin ELISA is intended for use in the quantitative determination of beta-2-microglobulin in human serum. | JZG | System, Test, Beta-2-Microglobulin Immunological | 2 | Beta-2 Microglobulin ELISA |
| 29 | B24211TESHUE010 | 11-TESHU-E01 | 11-TESHU-E01 | Intended for the direct quantitative determination of Testosterone by an enzyme Intended for the direct quantitative determination of Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use. | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | Serum Testosterone ELISA |
| 30 | B24210EXBUF2250 | 10-EXBUF-225 | 10-EXBUF-225 | General purpose reagent used in preparation of samples for ALPCO stool-based bio General purpose reagent used in preparation of samples for ALPCO stool-based biomarker kits. | PPM | General Purpose Reagent | 1 | Extraction Buffer 4X, 225mL Fill |
| 31 | B24280INSHUCH010 | 80-INSHU-CH01 | 80-INSHU-CH01 | The ALPCO Insulin Chemiluminescence ELISA is designed for the quantitative deter The ALPCO Insulin Chemiluminescence ELISA is designed for the quantitative determination of insulin in human serum, heparin plasma, and tissue culture supernatants. For in vitro diagnostic use. | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | STELLUX® Chemi Human Insulin ELISA |
| 32 | B24280CPTHUCH050 | 80-CPTHU-CH05 | 80-CPTHU-CH05 | The ALPCO STELLUX® C-peptide Chemiluminescence ELISA is designed for the quantit The ALPCO STELLUX® C-peptide Chemiluminescence ELISA is designed for the quantitative determination of C-peptide in human serum, heparin plasma, EDTA plasma, and tissue culture supernatants. For In Vitro Diagnostic Use. | JKD | Radioimmunoassay, C-Peptides Of Proinsulin | 1 | STELLUX® Chemi Human C-peptide ELISA Lab Pack |
| 33 | B24280CALPHUCH500 | 80-CALPHU-CH50 | 80-CALPHU-CH50 | The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemilu The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings. | NXO | Calprotectin, Fecal | 2 | ALPCO Calprotectin Chemiluminescence ELISA |
| 34 | B24280CALPHUCH010 | 80-CALPHU-CH01 | 80-CALPHU-CH01 | The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemilu The ALPCO Calprotectin Chemiluminescence ELISA is an in vitro diagnostic chemiluminescent assay intended for the quantitative measurement of fecal calprotectin, a neutrophilic protein that is a marker of intestinal mucosal inflammation, in human stool. The ALPCO Calprotectin Chemiluminescence ELISA is intended for in vitro diagnostic use as an aid in the diagnosis of inflammatory bowel disease (IBD), specifically Crohn’s disease (CD) and ulcerative colitis (UC), and as an aid in the differentiation of IBD from irritable bowel syndrome (IBS) in conjunction with other clinical and laboratory findings. | NXO | Calprotectin, Fecal | 2 | ALPCO Calprotectin Chemiluminescence ELISA |
| 35 | B24235TGAHUE010 | 35-TGAHU-E01 | 35-TGAHU-E01 | The Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA is a solid phase enzyme im The Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. Each device contains the following: microplate strips with breakaway microwells coated with recombinant human tTG and Gliadin-specific peptide antigen, six levels of calibrators (0, 3, 10, 30, 100, 300 U/mL); positive, negative and cut-off controls (human serum, diluted); wash buffer concentrate; sample buffer; goat anti-human immunoglobulin (IgG) horseradish peroxidase conjugate; 3,3’,5,5’ tetramethylbenzidine (TMB)/H2O2 substrate; and 1M hydrochloric acid stop solution. | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | Anti Tissue Transglutaminase-A (Anti-tTg-A) ELISA |
| 36 | B24211PROHUE010 | 11-PROHU-E01 | 11-PROHU-E01 | Intended for the direct quantitative determination of Progesterone by enzyme imm Intended for the direct quantitative determination of Progesterone by enzyme immunoassay using human serum. For in vitro diagnostic use. | JLS | Radioimmunoassay, Progesterone | 1 | Progesterone ELISA |
| 37 | B24211ANRHUE010 | 11-ANRHU-E01 | 11-ANRHU-E01 | The Androstenedione ELISA is for the direct quantitative determination of andros The Androstenedione ELISA is for the direct quantitative determination of androstenedione in human serum by an enzyme immunoassay. For In Vitro Diagnostic Use. | CIZ | Radioimmunoassay, Androstenedione | 1 | Androstenedione ELISA |
| 38 | B24280PANHUCH500 | 80-PANHU-CH50 | 80-PANHU-CH50 | The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the determination of pancreatic elastase (PE) in human stool. This assay detects both the CELA3A and CELA3B isoforms of pancreatic elastase. | JNN | P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | 1 | Pancreatic Elastase Chemiluminescence ELISA |
| 39 | B24280PANHUCH010 | 80-PANHU-CH01 | 80-PANHU-CH01 | The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the The Pancreatic Elastase Chemiluminescence ELISA is a quantitative assay for the determination of pancreatic elastase (PE) in human stool. This assay detects both the CELA3A and CELA3B isoforms of pancreatic elastase. | JNN | P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | 1 | Pancreatic Elastase Chemiluminescence ELISA |
| 40 | B24280INSHUUE100 | 80-INSHUU-E10 | 80-INSHUU-E10 | The ALPCO Ultrasensitive Insulin ELISA Jumbo is designed for the quantitative de The ALPCO Ultrasensitive Insulin ELISA Jumbo is designed for the quantitative determination of insulin in human serum and plasma. For in vitro diagnostic use. | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | ALPCO Ultrasensitive Insulin ELISA Jumbo |
| 41 | B24235TGGHUE010 | 35-TGGHU-E01 | 35-TGGHU-E01 | The Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA is a solid phase enzyme im The Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against neo-epitopes of tissue transglutaminase (tTG) in human serum. Each device contains the following: microplate strips with breakaway microwells coated with recombinant human tTG and Gliadin-specific peptide antigen, six levels of calibrators (0, 3, 10, 30, 100, 300 U/mL); positive, negative and cut-off controls (human serum, diluted); wash buffer concentrate; sample buffer; goat anti-human immunoglobulin (IgG) horseradish peroxidase conjugate; 3,3’,5,5’ tetramethylbenzidine (TMB)/H2O2 substrate; and 1M hydrochloric acid stop solution. | MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 | Anti Tissue Transglutaminase-G (Anti-tTG-G) ELISA |
| 42 | B24225TSHHUUE010 | 25-TSHHUU-E01 | 25-TSHHUU-E01 | The Thyroid Stimulating Hormone (TSH) Ultrasensitive ELISA is intended for use i The Thyroid Stimulating Hormone (TSH) Ultrasensitive ELISA is intended for use in the quantitative determination of thyroid stimulating hormone (TSH) concentration in human serum. The assay is useful in the diagnosis of thyroid or pituitary disorders. | JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | Thyroid Stimulating Hormone (TSH) Ultrasensitive ELISA |
| 43 | B24211ESRHUE010 | 11-ESRHU-E01 | 11-ESRHU-E01 | Intended for the direct quantitative determination of Estrone by an enzyme immun Intended for the direct quantitative determination of Estrone by an enzyme immunoassay in human serum. For In Vitro Diagnostic Use. | CGF | Radioimmunoassay, Estrone | 1 | Estrone ELISA |
| 44 | B24220TGF1HUE010 | 20-TGF1HU-E01 | 20-TGF1HU-E01 | The TGF Beta-1 ELISA is an enzyme immunoassay for the quantitative in vitro diag The TGF Beta-1 ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of TGF Beta-1 in serum and cell culture supernatant. For in vitro diagnostic use. | CFL | Radioimmunoassay, Human Growth Hormone | 1 | TGF Beta-1 ELISA |
| 45 | B24220FE3HUE010 | 20-FE3HU-E01 | 20-FE3HU-E01 | The Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitro di The Free Estriol ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of free estriol (unconjugated estriol) in serum during the second half of pregnancy. | CGI | Radioimmunoassay, Estriol | 1 | Free Estriol ELISA |
| 46 | B24220DHSHUE010 | 20-DHSHU-E01 | 20-DHSHU-E01 | The DHEA-S ELISA is an enzyme immunoassay for the quantitative in vitro diagnost The DHEA-S ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of DHEA-S in serum and plasma. | JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 1 | DHEA-S ELISA |
| 47 | B24211FTEHUE010 | 11-FTEHU-E01 | 11-FTEHU-E01 | For the direct quantitative determination of Free Testosterone by an enzyme immu For the direct quantitative determination of Free Testosterone by an enzyme immunoassay in human serum. For in vitro diagnostic use. | CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | Free Testosterone ELISA |
| 48 | B24280INSHUE010 | 80-INSHU-E01.1 | 80-INSHU-E01.1 | The ALPCO Insulin ELISA is designed for the quantitative determination of insuli The ALPCO Insulin ELISA is designed for the quantitative determination of insulin in serum and plasma. For in vitro diagnostic use. | CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | ALPCO Insulin ELISA |
| 49 | B24280CPTHUCH010 | 80-CPTHU-CH01 | 80-CPTHU-CH01 | The ALPCO STELLUX™ C-peptide Chemiluminescence ELISA is designed for the quantit The ALPCO STELLUX™ C-peptide Chemiluminescence ELISA is designed for the quantitative determination of C-peptide in human serum, heparin plasma, EDTA plasma, and tissue culture supernatants. For In Vitro Diagnostic Use. | JKD | Radioimmunoassay, C-Peptides Of Proinsulin | 1 | STELLUX® Chemi Human C-peptide ELISA |
| 50 | B24230PANHUE010 | 30-PANHU-E01 | 30-PANHU-E01 | The Pancreatic Elastase ELISA is intended for the quantitative determination of The Pancreatic Elastase ELISA is intended for the quantitative determination of pancreatic elastase in human stool samples. For In Vitro Diagnostic Use. | JNN | P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin | 1 | Pancreatic Elastase ELISA |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00817273020402 | 720-830 | "720-830 anti-β2 Glycoprotein I IgG/IgM Test Kit" | Diamedix | DIAMEDIX CORPORATION | |
| 2 | 00816879020243 | FGA24 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgA antibodies in human serum | Autostat II Anti-B2-Glycoprotein I IgA | HYCOR BIOMEDICAL LLC | |
| 3 | 00816879020236 | FGA23 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgM antibodies in human serum | Autostat II Anti-B2-Glycoprotein I IgM | HYCOR BIOMEDICAL LLC | |
| 4 | 00816879020229 | FGA22 | 96 well ELISA for the detection of Anti-B2-Glycoprotein I IgG antibodies in human serum | Autostat II Anti-B2-Glycoprotein I IgG | HYCOR BIOMEDICAL LLC | |
| 5 | B24235B2SHUE010 | 35-B2SHU-E01 | 35-B2SHU-E01 | Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employ Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employing native Beta-2glycoprotein I highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against Beta-2-glycoprotein I in human serum. | Anti-Beta 2 Glycoprotein Screen ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 6 | 08426951298778 | 00009800015 | 00009800015 | 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Re 1. HemosIL Acustar ß2GP1-Domain1 Reagent Cartridge (Cat. No. 000098000162. 1 Resuspension buffer (Cat. No. 00009800019) 3. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 1 (Cat. No. 00009800017):4. 1 HemosIL Acustar ß2GP1-Domain1 Calibrator 2 (Cat. 00009800018): | HemosIL AcuStar Anti-B2GPI Domain 1 | INSTRUMENTATION LABORATORY COMPANY |
| 7 | 08426951289271 | 701250 | 1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgM Calibr 1. 1 QUANTA Flash B2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgM Calibrator 1 3. 1 QUANTA Flash B2GP1 IgM Calibrator 2 | QUANTA Flash® B2GP1 IgM Reagents | INOVA DIAGNOSTICS, INC. | |
| 8 | 08426951289264 | 701245 | 1 QUANTA Flash B2GP1 IgG Reagent Cartridge1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Reagent Cartridge1 QUANTA Flash B2GP1 IgG Calibrator 1 1 QUANTA Flash B2GP1 IgG Calibrator 2 | QUANTA Flash® B2GP1 IgG Reagents | INOVA DIAGNOSTICS, INC. | |
| 9 | 08426951289257 | 701240 | 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgA Calibra 1. 1 QUANTA Flash B2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash B2GP1 IgA Calibrator 1 3. 1 QUANTA Flash B2GP1 IgA Calibrator 2 | QUANTA Flash® B2GP1 IgA Reagents | INOVA DIAGNOSTICS, INC. | |
| 10 | 08426950601951 | 701188 | 1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge2. 1 Resuspension buffer 3. 1 T 1. 1 QUANTA Flash ß2GP1-Domain1 Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet4. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 15. 1 QUANTA Flash ß2GP1-Domain1 Calibrator 2 | QUANTA Flash® B2GP1-Domain 1Reagents | INOVA DIAGNOSTICS, INC. | |
| 11 | 08426950596820 | 701243 | 1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash ß2GP1 IgA Calibra 1. 1 QUANTA Flash ß2GP1 IgA Reagent Cartridge2. 1 QUANTA Flash ß2GP1 IgA Calibrator 1 3. 1 QUANTA Flash ß2GP1 IgA Calibrator 2 | QUANTA Flash® β2GPI IgA Reagents | INOVA DIAGNOSTICS, INC. | |
| 12 | 08426950595816 | 708665.10 | 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgG ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 13 | 08426950594659 | 708675.10 | 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pr 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgA ELISA Control4. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 5x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgA ELISA Bulk Pack | INOVA DIAGNOSTICS, INC. | |
| 14 | 08426950594543 | 708665.10L | 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pre 1. 10 B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgG ELISA Control4. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® B2 GPI IgG ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
| 15 | 08426950594529 | 708670.10L | 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL pr 1. 10x B2 GPI ELISA microwell plates (12-1 x 8 wells), with holder2. 5x 1.2mL prediluted ELISA Negative Control 3. 5x 1.2mL prediluted 2 GPI IgM ELISA Control4. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator A5. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator B6. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator C7. 5x 1.2mL prediluted 2 GPI IgM ELISA Calibrator D8. 5 x1.2mL prediluted 2 GPI IgM ELISA Calibrator E9. 9x 50mL HRP Sample Diluent10. 10x 25mL HRP Wash Concentrate, 40x concentrate11. 10x 10mL HRP IgM Conjugate, (goat), anti-human IgM12. 10x 10mL TMB Chromogen13. 10x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® B2 GPI IgM ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
| 16 | 08426950594482 | 708675.10L | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgA ELISA Control4. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA LITE® B2 GPI IgA ELISA Bulk Pack Kit (Lab Corp) | INOVA DIAGNOSTICS, INC. | |
| 17 | 08426950594475 | 701253 | 1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash β2GP1 IgM Calibra 1. 1 QUANTA Flash β2GP1 IgM Reagent Cartridge2. 1 QUANTA Flash β2GP1 IgM Calibrator 1 3. 1 QUANTA Flash β2GP1 IgM Calibrator 2 | QUANTA Flash® β2GPI IgM Reagents | INOVA DIAGNOSTICS, INC. | |
| 18 | 08426950594420 | 701248 | 1. QUANTA Flash β2GP1 IgG Reagent Cartridge1. QUANTA Flash β2GP1 IgG Calibrator 1. QUANTA Flash β2GP1 IgG Reagent Cartridge1. QUANTA Flash β2GP1 IgG Calibrator 1 1. QUANTA Flash β2GP1 IgG Calibrator 2 | QUANTA Flash® β2GPI IgG Reagents | INOVA DIAGNOSTICS, INC. | |
| 19 | 08426950593157 | 708675 | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgA ELISA Control4. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgA ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL HRP IgA Conjugate, (goat), anti-human IgA12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgA | INOVA DIAGNOSTICS, INC. | |
| 20 | 08426950496984 | 0009802016 | 0009802016 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM | HemosIL AcuStar Anti-B2 Glycoprotein-I IgM | INSTRUMENTATION LABORATORY COMPANY |
| 21 | 08426950496977 | 0009802012 | 0009802012 | HemosIL AcuStar Anti-B2 Glycoprotein-I IgG | HemosIL AcuStar Anti-B2 Glycoprotein-I IgG | INSTRUMENTATION LABORATORY COMPANY |
| 22 | 08426950485971 | 708670 | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2GPI IgM ELISA Control4. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator A5. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator B6. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator C7. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator D8. 1x 1.2mL prediluted β2GPI IgM ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x10mL HRP IgM Conjugate, (goat), anti-human IgM12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgM ELISA | INOVA DIAGNOSTICS, INC. | |
| 23 | 08426950454472 | 708660 | 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2 1. 1x β2 GPI Screen ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted β2 GPI Decision Point4. 1x 1.2mL prediluted β2 GPI Screening Control5. 1x 50mL HRP Sample Diluent6. 1x 25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgGAM Conjugate, (goat), anti-human8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI Screening ELISA | INOVA DIAGNOSTICS, INC. | |
| 24 | 08426950451112 | 708665 | 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x B2 GPI ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted 2 GPI IgG ELISA Control4. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator A5. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator B6. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator C7. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator D8. 1x 1.2mL prediluted 2 GPI IgG ELISA Calibrator E9. 1x 50mL HRP Sample Diluent10. 1x 25mL HRP Wash Concentrate, 40x concentrate11. 1x 10mL 2 HRP IgG Conjugate, (goat), anti-human IgG12. 1x 10mL TMB Chromogen13. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® β2GPI IgG ELISA | INOVA DIAGNOSTICS, INC. | |
| 25 | 07340058410158 | FBGP100 | FBGP100 | DIASTAT anti-B2-Glycoprotein-1 IgM | EURO-DIAGNOSTICA AB | |
| 26 | 07340058410141 | FBGP200 | FBGP200 | DIASTAT anti-B2 Glycoprotein-1 IgG | EURO-DIAGNOSTICA AB | |
| 27 | 07333066014760 | DECC055330 | DECC055330 | EliA ß2-Glycoprotein I IgM Well | EliA ß2-Glycoprotein I IgM Well | PHADIA AB |
| 28 | 07333066014753 | DECC055320 | DECC055320 | EliA ß2-Glycoprotein I IgG Well | EliA ß2-Glycoprotein I IgG Well | PHADIA AB |
| 29 | 07333066014746 | DECC055310 | DECC055310 | EliA ß2-Glycoprotein I IgA Well | EliA ß2-Glycoprotein I IgA Well | PHADIA AB |
| 30 | 04250289503099 | 7215US | 7215US | AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-Check | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 31 | 04250289503082 | 7206US | 7206US | AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-GM | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 32 | 04250289503075 | 7205US | 7205US | AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 gly AESKULISA b2 Glyco-A is a solid phase enzyme immunoassay employing native b2 glycoprotein I highly purified from human plasma for the semiquantitative and qualitative detection of IgA antibodies against ß2 glycoprotein I in human serum. The presence of anti-b2 glycoprotein I antibodies in conjuction with clinical findings and other laboratory results can be used as an aid in the diagnosis of thrombotic disorders related to primary andsecondary antiphospholipid syndrome. | AESKULISA® ß2-Glyco-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 33 | 04250289502849 | 30-7215US | 30-7215US | AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation. | AESKULISA® ß2-Glyco-Check | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 34 | 04250289502832 | 30-7206US | 30-7206US | AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS).30'+30'+30' automation incubation. | AESKULISA® ß2-Glyco-GM | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 35 | 04250289502825 | 30-7205US | 30-7205US | AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. 30'+30'+30' automation incubation. | AESKULISA® ß2-Glyco-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 36 | 04250289500951 | 3215 | AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2 AESKULISA β2-Glyco-Check is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-Check | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 37 | 04250289500869 | 3206 | AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2gly AESKULISA β2-Glyco-GM is a solid phase enzyme immunoassay employing native β2glycoproteinI highly purified from human plasma for the separate quantitative and qualitative detection of IgG and / or IgM antibodies against β2-glycoprotein I in human serum. Anti-β2glycoprotein I antibodies recognize specific epitopes on human β2-glycoprotein I which are expressed only when β2-glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome (APS). | AESKULISA® ß2-Glyco-GM | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 38 | 04250289500852 | 3205 | AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 gly AESKULISA β2 Glyco-A is a solid phase enzyme immunoassay employing native β2 glycoprotein I highly purified from human plasma for the quantitative and qualitative detection of IgA antibodies against β2 glycoprotein I in human serum. Anti-β2 glycoprotein I antibodies recognize specific epitopes on human β2 glycoprotein I which are expressed only when β2 glycoprotein I interacts with lipid membranes or when absorbed to other surfaces (e.g. microtiter plate). The assay is an aid in the diagnosis and risk of primary and secondary antiphospholipid syndrome. | AESKULISA® ß2-Glyco-A | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 39 | 00855360006236 | 11854 | 11854 | INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibo INTENDED USEAn enzyme-linked immunoassay (ELISA) for the detection of IgG antibodies to complexes formed byoxidized low-density lipoprotein (oxLDL) with β2-glycoprotein I (β2GPI) in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (antiphospholipid syndrome). For In Vitro Diagnostic Use Only.SUMMARY AND EXPLANATION OF THE ASSAYThe antiphospholipid syndrome (APS) is one of the most common causes of acquired hypercoagulability(thrombophilia) It is frequently diagnosed in the context of a systemic autoimmune disorder such asSLE (secondary APS), however, it may also occur in the absence of an obvious underlying disease(primary APS). Oxidative stress and oxLDL formation are common in patients with SLE and APS suggesting an important relationship between lipid peroxidation and clotting activation (hypercoagulability). The presence of circulating IgG anti-oxLDL-β2GPI antibodies seem to be etiologically important. PRINCIPLE OF THE TESTThis test is an indirect ELISA detecting IgG anti-oxLDL-β2GPI antibodies. Diluted serum samples, calibrator(s), and controls are incubated in microwells coated with the oxLDL- β2GPI complex. After the removal of unbound serum proteins by washing, anti-human IgG antibodies, labeled with horseradish peroxidase (HRP), are added. Following another wash, the bound enzyme-antibody conjugate is assayed by the addition of tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of IgG anti-oxLDL-β2GPI antibody. Results are obtained by reading the OD of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-oxLDL-β2GPI antibody concentration expressed in G Units. A log-log regression analysis is performed with calibrator values plotted against calibrator mean O.D.’s. Controls and patient results are determined from the calibration curve. Refer to product package insert. | Anti-AtherOxTM IgG Test Kit (OxLDL-B2GPI IgG Antibody) | CORGENIX MEDICAL CORPORATION |
| 40 | 00855360006199 | 13372 | 13372 | INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to product package insert. | Corgenix Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
| 41 | 00855360006182 | 13371 | 13371 | INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl.. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product package insert. | Corgenix Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
| 42 | 00855360006175 | 13370 | 13370 | INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodie INTENDED USE For the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY AND EXPLANATION OF THE I TEST Anti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgG anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome. PRINCIPLE OF THE TEST The test is s an indirect ELISA. Diluted serum/ plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum/plasma proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-β2GPl antibody concentrations expressed in G units.. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. | Corgenix Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
| 43 | 00855360006168 | 038-001 | 038-001 | INTENDED USEFor the detection and semi-quantitation of IgM anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgM anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionicphospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgM anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgM anti-β2GPl antibody concentrations expressed in M units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. | REAADS Anti-Beta 2 Glycoprotein I IgM Semi-Quantitative Test Kit (96 Well) | CORGENIX MEDICAL CORPORATION |
| 44 | 00855360006151 | 037-001 | 037-001 | INTENDED USEFor the detection and semi-quantitation of IgG anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgG anti-β2GPl antibodies in individuals with systemic lupuserythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgG anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgG, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgG anti-β2GPl antibody concentrations expressed in G units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. | REAADS Anti-Beta 2 Glycoprotein I IgG Semi-Quantitative Test Kit (96 Well) | CORGENIX MEDICAL CORPORATION |
| 45 | 00855360006144 | 039-001 | 039-001 | INTENDED USEFor the detection and semi-quantitation of IgA anti-β2GPl antibodies INTENDED USEFor the detection and semi-quantitation of IgA anti-β2GPl antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Use Only.SUMMARY OF THE TESTAnti-phospholipid antibodies are a heterogeneous group of immunoglobulins that bind to several anionic phospholipids, including cardiolipin and phosphatidylserine. High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (e.g., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. Patients with positive reactions to both anti-phospholipid and anti-β2GPl assays were more likely to have clinical complications than those positive for only one. Higher prevalence and mean serum levels of IgA anti-β2GPl antibodies have been reported in autoimmune patients. In addition, anti-β2GPl antibodies in SLE patients correlated with clinical manifestations of anti-phospholipid syndrome.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in microwells coated with purified human β2GPl. After the removal of unbound serum or plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the β2GPl bound antibodies. Following another wash step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells at an intensity proportional to the serum concentration of anti-β2GPl antibodies. Results are obtained by reading the O.D. of each well in a spectrophotometer. Calibrator sera are provided, with the IgA anti-β2GPl antibody concentrations expressed in A units. Controls and patient results are determined from the calibration curve. Refer to Product Package Insert. | REAADS Anti-Beta 2 Glycoprotein I IgA Semi-Quantitative Test Kit (96 Well) | CORGENIX MEDICAL CORPORATION |
| 46 | 00847865012997 | SW4.1_1 | 6652165B | Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 47 | 00847865012980 | SW4.1V1 | 6652065B | Manual & CDs, APLS IgM IFU, SW4.1_v1 | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 48 | 00847865012973 | SW4.1V1 | 6651975B | APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 49 | 00847865012966 | SW4.1V1 | 6651965B | Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |
| 50 | 00847865012522 | SW4_1 | 6651965A | Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only | BioPlex 2200 | BIO-RAD LABORATORIES, INC. |