| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B350GSD341600R0 | GSD34-1600-R | GSD34-1600-R | Rapid Plasma Reagin (RPR) Reagent Pack | Gold Standard Diagnostics RPR Reagent Pack | |||
| 2 | B350GSD0110260 | GSD01-1026 | GSD01-1026 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit |
| 3 | B350GSD011002HCP0 | GSD01-1002-HCP | GSD01-1002-HCP | H. pylori Component Pack | PPM | General Purpose Reagent | 1 | H. pylori Component Pack |
| 4 | B3507206300 | 720-630 | 720-630 | ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determinatio ImmunoSimplicity (Is) EBNA-1 IgM ELISA Test Kit for the qualitative determination of IgM antibodies to Epstein-Bar Virus Nuclear Antigen-1 (EBNA-1 IgM) in human serum by indirect enzyme immunoassay. | LSE | Epstein-Barr Virus, Other | 1 | Gold Standard Diagnostics Is-EBNA-1 IgM ELISA Test Kit |
| 5 | B3507205200 | 720-520 | 720-520 | ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to me ImmunoSimplicity (Is) Measles IgG Test for the detection of IgG antibodies to measles virus as an aid in the assessment of the patient's immunological response to measles and to determine the immune status of individuals, and as an aid in the diagnosis of measles infection. | LJB | Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | 1 | Gold Standard Diagnostics Is-Measles IgG ELISA Test Kit |
| 6 | B3507203200 | 720-320 | 720-320 | ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytome ImmunoSimplicity (Is) CMV IgG Test for the detection of IgG antibodies to cytomegalovirus (CMV) as an aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals. | LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 | Gold Standard Diagnostics Is-CMV IgG ELISA Test Kit |
| 7 | B350GSD1600WCASE0 | GSD-1600-W-CASE | GSD-1600-W-CASE | Microtiterplates 48-well microtiter plates - bulk | GMQ | Antigens, Nontreponemal, All | 2 | Microtiterplates |
| 8 | B350GSD0610190 | GSD06-1019 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit - Bulk | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgM Line Blot Test Kit | |
| 9 | B350GSD0130020 | GSD01-3002 | GSD01-3002 | Trichinella spiralis IgG ELISA Test Kit | MDT | Elisa, Trichinella Spiralis | 1 | Trichinella spiralis IgG ELISA Test Kit |
| 10 | B350GSD0130000 | GSD01-3000 | GSD01-3000 | Toxocara canis IgG ELISA Test Kit | MDJ | Reagents, Cysticercosis | 1 | GSD Toxocara canis IgG ELISA |
| 11 | B350GSD0110280 | GSD01-1028 | GSD01-1028 | Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit for the qualitative detection of IgG antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Gold Standard Diagnostics SARS-CoV-2 IgG ELISA Test Kit | |
| 12 | B350GSD0110270 | GSD01-1027 | GSD01-1027 | Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi VIsE-OspC ELISA IgG/ IgM Test Kit |
| 13 | B350GSD0110250 | GSD01-1025 | GSD01-1025 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit |
| 14 | B350GSD0110240 | GSD10-1024 | GSD10-1024 | Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgodorferi IgG/IgM ELISA Test Kit |
| 15 | B350GSD0110010 | GSD01-1001 | Gold Standard Diagnostics H. pylori ELISA IgA Test Kit | LYR | Helicobacter Pylori | 1 | Gold Standard Diagnostics H. pylori ELISA IgA Test Kit | |
| 16 | B3507203600 | 720-360 | 720-360 | ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-qu ImmunoSimplicity (Is) Rubella IgG ELISA Test Kit for the qualitative and semi-quantitative detection of IgG antibodies to rubella in human serum to aid in the assessment of the patient's immunological response to rubella and in the determination of the immune status of individuals, including females of child bearing age. | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | Gold Standard Diagnostics Is-Rubella IgG ELISA Test Kit |
| 17 | B350005000 | 00500 | 00500 | Bolt EIA | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Bolt |
| 18 | B350GSD0130070 | GSD01-3007 | GSD01-3007 | Brucella IgG ELISA Test Kit | GSM | Antisera, Fluorescent, Brucella Spp. | 2 | GSD Brucella IgG ELISA |
| 19 | B350GSD0130010 | GSD01-3001 | GSD01-3001 | Toxocara canis IgG ELISA Test Kit | MDJ | Reagents, Cysticercosis | 1 | Toxocara canis IgG ELISA Test Kit |
| 20 | B35000300CL0 | 00300-CL | 00300CL | ThunderBolt EIA-CLIA | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ThunderBolt EIA (CLIA) |
| 21 | B350GSD1010220 | GSD10-1022 | GSD10-1022 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - 10 Pack | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit |
| 22 | B350GSD0610180 | GSD06-1018 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit - Bulk | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit | |
| 23 | B350GSD051700AW0 | GSD05-1700-AW | GSD05-1700-AW | HHV-6 IgG Plates - Bulk | MVU | Reagents, Specific, Analyte | 1 | HHV-6 IgG Plates - Bulk |
| 24 | B350GSD011029CP0 | GSD01-1029-CP | GSD01-1029-CP | SARS-CoV-2 Component Pack | PPM | General Purpose Reagent | 1 | SARS-CoV-2 Component Pack |
| 25 | B350GSD0110220 | GSD01-1022 | GSD01-1022 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit |
| 26 | B350GSD0110180 | GSD01-1018 | GSD01-1018 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgodorferi B31 IgG Line Blot Test Kit |
| 27 | B3507203500 | 720-350 | 720-350 | ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM antibodies to he ImmunoSimplicity (Is) HSV 1&2 IgM Test for the detection of IgM antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV. | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Gold Standard Diagnostics Is-HSV 1&2 IgM ELISA Test Kit |
| 28 | B350GSD0410220 | GSD04-1022 | GSD04-1022 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk Pack | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgG Line Blot Test Kit - Bulk |
| 29 | B3507205400 | 720-540 | 720-540 | ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-q ImmunoSimplicity (Is) Mumps IgG ELISA Test Kit is for the qualitative and semi-quantitative determination of IgG antibodies to Mumps virus in human serum of adults over eighteen years of age by indirect enzyme immunoassay as an aid in the diagnosis of Mimps infection. | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | Gold Standard Diagnostics Is-Mumps IgG ELISA Test Kit |
| 30 | B3507202800 | 720-280 | 720-280 | ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies ImmunoSimplicity (Is) Anti-Scl-70 ELISA Test Kit for the detection of antibodies against Scl-70 in human serum as an aid in the diagnosis of autoimmune disease. | LLL | Extractable Antinuclear Antibody, Antigen And Control | 2 | Gold Standard Diagnostics Is-anti-Scl-70 ELISA Test Kit |
| 31 | B350GSD051700CP0 | GSD05-1700-CP | GSD05-1700-CP | IgG Component Pack - Bulk | PPM | General Purpose Reagent | 1 | IgG Component Pack - Bulk |
| 32 | B350GSD0130100 | GSD01-3010 | GSD01-3010 | Gold Standard Diagnostics Influenza B IgG ELISA Test Kit | GNW | Antisera, Cf, Influenza Virus A, B, C | 1 | Influenza B IgG ELISA Test Kit |
| 33 | B350GSD0110300 | GSD01-1030 | GSD01-1030 | Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit for the qualitative detection of IgM antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Gold Standard Diagnostics SARS-CoV-2 IgM ELISA Test Kit | |
| 34 | B350GSD011029SP0 | GSD01-1029-SP | GSD01-1029-SP | SARS-CoV-2 IgA Sera PackAnalyte Specific Reagent | MVU | Reagents, Specific, Analyte | 1 | SARS-CoV-2 IgA Sera Pack |
| 35 | B35000500CL0 | 00500-CL | 00500CL | Bolt EIA-CLIA | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | Bolt (CLIA) |
| 36 | B350003000 | 00300 | 00300 | JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | ThunderBolt EIA | |
| 37 | B350GSD0116000 | GSD01-1600 | Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test Kit | GMQ | Antigens, Nontreponemal, All | 2 | Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System | |
| 38 | B350GSD011002CP0 | GSD01-1002-CP | GSD01-1002-CP | H. pylori IgM Sera Pack | MVU | Reagents, Specific, Analyte | 1 | H. pylori IgM Sera Pack |
| 39 | B350GSD0110000 | GSD01-1000 | Gold Standard Diagnostics Helicobacter pylori IgG ELISA Test Kit | LYR | Helicobacter Pylori | 1 | Gold Standard Diagnostics H. pylori ELISA IgG Test Kit | |
| 40 | B3507203400 | 720-340 | 720-340 | ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to he ImmunoSimplicity (Is) HSV 1&2 IgG Test for the detection of IgG antibodies to herpes simplex virus (HSV) type 1 and/or type 2 as an aid in the diagnosis of a primary or reactivated infection with HSV. | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | Gold Standard Diagnostics Is-HSV 1&2 IgG ELISA Test Kit |
| 41 | B350004000 | 00400 | AIX1000 Rapid Plasma Reagin (RPR) Analyzer | GMQ | Antigens, Nontreponemal, All | 2 | AIX1000 Analyzer | |
| 42 | B350GSD1010230 | GSD10-1023 | GSD10-1023 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - 10 Pack | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit |
| 43 | B350GSD0410230 | GSD04-1023 | GSD04-1023 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk Pack | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit - Bulk |
| 44 | B350GSD0110290 | GSD01-1029 | GSD01-1029 | Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative dete Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit for the qualitative detection of IgA antibodies to SARS-CoV-2 virus to aid in the diagnosis of Coronavirus (COVID-19). | QJR | Reagents, 2019-Novel Coronavirus Nucleic Acid | Gold Standard Diagnostics SARS-CoV-2 IgA ELISA Test Kit | |
| 45 | B350GSD0110230 | GSD01-1023 | GSD01-1023 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit |
| 46 | B350GSD0110190 | GSD01-1019 | GSD01-1019 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit | LSR | Reagent, Borrelia Serological Reagent | 2 | Gold Standard Diagnostics Borrelia burgdorferi B31 IgM Line Blot Test Kit |
| 47 | B3507203800 | 720-380 | 720-380 | ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitat ImmunoSimplicity Varicella Zoster Virus (Is-VZV) IgG ELISA test for the qualitative and semi-quantitative detection of IgG antibodies to VZV to determine a prior exposure to VZV and to aid in the determination of acute or convalescent stage of VZV infection. | LFY | Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | 2 | Gold Standard Diagnostics Is-VZV IgG ELISA Test Kit |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00657498001288 | 1160-050 | 1160-050 | Latex Agglutination Slide Test for the Detection and Quantitation of serum antin Latex Agglutination Slide Test for the Detection and Quantitation of serum antinucleoprotein factors associated with systemic Lupus Erythematosis in Human Serum. | RaPET® s-LE | STANBIO LABORATORY, L.P. |
| 2 | 00613745051895 | 800-5189 | 5189 | The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories. | ImmunoDOT Autoimmunity Panel 1 | GENBIO |
| 3 | 00613745051253 | 800-5125 | 5125 | The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test The ImmunoDOT Autoimmunity Screening Panel 1 is an enzyme immunoassay (EIA) test for screening and detection of autoantibodies against various specific nuclear antigens in serum and heparinized whole blood and used as an aid in the diagnosis of autoimmune disorders. This product is intended for use in physician offices and clinical laboratories. | ImmunoDOT Autoimmunity Panel 1 | GENBIO |
| 4 | 00613745039206 | 800-3920 | 3920 | Substitute Negative Control for specimen. Otherwise follow the Procedure as desc Substitute Negative Control for specimen. Otherwise follow the Procedure as described in the ImmunoDOT Test package insert. | ImmunoDOT Negative Control | GENBIO |
| 5 | 00613745039183 | 800-3918 | 3918 | Substitute Serum Control D for specimen. Otherwise follow the Procedure as descr Substitute Serum Control D for specimen. Otherwise follow the Procedure as described in the ImmunoDOT Autoimmunity Test package insert. | ImmunoDOT Serum Control D | GENBIO |
| 6 | 00404847435801 | EIA-3580 | EIA-3580 | Anti-Scl-70 ELISA is a test system for the quantitative measurement of IgG class Anti-Scl-70 ELISA is a test system for the quantitative measurement of IgG class autoantibodies against Scl-70 in human serum or plasma. | Anti-Scl-70 ELISA | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 7 | B350GSD0113000 | GSD01-1300 | Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit | Gold Standard Diagnostics Anti-nuclear Antibody (ANA) Screening Test Kit | GOLD STANDARD DIAGNOSTICS CORPORATION | |
| 8 | 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. | ENA-6Pro ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 9 | 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. | ANA-8Pro ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. |
| 10 | 08426950595632 | 701198 | 1. 1 QUANTA Flash Centromere Reagent Cartridge2. 1 Resuspension buffer 3. 1 Transfer pipet | QUANTA Flash® Centromere Reagents | INOVA DIAGNOSTICS, INC. | |
| 11 | 08426950593744 | 708525 | 1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL pred 1. 1x ssDNA ELISA microwell plate (12-1 x 8 wells), with holder2. 1x 1.2mL prediluted ELISA Negative Control 3. 1x 1.2mL prediluted ssDNA ELISA Low Positive4. 1 x1.2mL prediluted ssDNA ELISA High Positive5. 1 x50mL HRP Sample Diluent6. 1 x25mL HRP Wash Concentrate, 40x concentrate7. 1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8. 1x 10mL TMB Chromogen9. 1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid" | QUANTA Lite® ssDNA ELISA | INOVA DIAGNOSTICS, INC. | |
| 12 | 08426950544128 | 708770 | (CENP-A & CENP-B)1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with ho (CENP-A & CENP-B)1.1x Centromere ELISA microwell plate (12-1 x 8 wells), with holder2.1x 1.2mL prediluted ELISA Negative Control 3.1x 1.2mL prediluted Centromere ELISA Low Positive4.1x 1.2mL prediluted Centromere ELISA High Positive5.1x 50mL HRP Sample Diluent6.1 x25mL HRP Wash Concentrate, 40x concentrate7.1x 10mL HRP IgG Conjugate, (goat), anti-human IgG8.1x 10mL TMB Chromogen9.1x 10mL HRP Stop Solution, 0.344M Sulfuric Acid | QUANTA Lite® Centromere ELISA | INOVA DIAGNOSTICS, INC. | |
| 13 | 07340058410509 | FAID200 | FAID200 | DIASTAT ENA Profile | EURO-DIAGNOSTICA AB | |
| 14 | 07333066014845 | DECC056370 | DECC056370 | EliA Scl-70S Well | EliA Scl-70S Well | PHADIA AB |
| 15 | 07333066014586 | DECC055070 | DECC055070 | EliA Jo-1 Well | EliA Jo-1 Well | PHADIA AB |
| 16 | 07333066014579 | DECC055060 | DECC055060 | EliA Scl-70 Well | EliA Scl-70 Well | PHADIA AB |
| 17 | 05391516747165 | 2337770 | 2337770 | Captia™ Histone | Trinity Biotech | CLARK LABORATORIES, INC. |
| 18 | 05391516743778 | 2337370 | 2337370 | Captia™ Sm/RNP | Trinity Biotech | CLARK LABORATORIES, INC. |
| 19 | 05391516743761 | 2337270 | 2337270 | Captia™ Smith (Sm) | Trinity Biotech | CLARK LABORATORIES, INC. |
| 20 | 05391516743747 | 2337070 | 2337070 | Captia™ SSA (Ro) | Trinity Biotech | CLARK LABORATORIES, INC. |
| 21 | 04260157080638 | ORG600 | ORG600 | ANA Detect is an ELISA test system for the qualitative measurement of IgG class ANA Detect is an ELISA test system for the qualitative measurement of IgG class autoantibodies against SS-A-52 (Ro-52), SS-A-60 (Ro-60), SS-B (La), RNP/Sm, RNP-70, RNP-A, RNP-C, Sm-BB, Sm-D, Sm-E, Sm-F, Sm-G, Scl-70, Jo-1, dsDNA, ssDNA, ssDNA, polynucleosomes, mononucleosomes, histone complex, histone H1, histone H2A, histone H2B, histone 3, histone H4, Pm-Scl-100 and centromere B in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only as an aid in the diagnosis of certain systematic rheumatic diseases. | ANA DETECT | ORGENTEC DIAGNOSTIKA GMBH |
| 22 | 04260157080102 | ORG513 | ORG513 | ANTI-JO-1 IS AN EILSA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS ANTI-JO-1 IS AN EILSA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST JO-1 IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-JO-1 | ORGENTEC DIAGNOSTIKA GMBH |
| 23 | 04260157080096 | ORG512 | ORG512 | ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLAS ANTI-SCL-70 IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SCL-70 IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PRFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SCI-70 | ORGENTEC DIAGNOSTIKA GMBH |
| 24 | 04260157080089 | ORG511 | ORG511 | ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLAS ANTI-RPN/SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST RNP/SM IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-RPN/SM | ORGENTEC DIAGNOSTIKA GMBH |
| 25 | 04260157080072 | ORG510 | ORG510 | ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AU ANTI-SM IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SM IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SM | ORGENTEC DIAGNOSTIKA GMBH |
| 26 | 04260157080065 | ORG509 | ORG509 | ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS ANTI-SS-B IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-B (La) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SS-B | ORGENTEC DIAGNOSTIKA GMBH |
| 27 | 04260157080058 | ORG508 | ORG508 | ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS ANTI-SS-A IS AN ELISA TEST SYSTEM FOR THE QUANTITATIVE MEASUREMENT OF IgG CLASS AUTOANTIBODIES AGAINST SS-A (52 AND 60kDa) IN HUMAN SERUM OR PLASMA. THIS PRODUCT IS INTENDED FOR PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY. | ANTI-SS-A | ORGENTEC DIAGNOSTIKA GMBH |
| 28 | 04250289503013 | 7113US | 7113US | AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histid AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyltRNA-synthetase (HRS) for the quantitative and qualitative detection of antibodies against Jo-1 (named after the prototype patient) in human serum. Human sera with anti-Jo-1 antibodies solely recognize HRS of higher eukaryotes and react with highest affinity with the human enzyme. The assay is a tool in the diagnosis of polymyositis and dermatomyositis. | AESKULISA® Jo-1 | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 29 | 04250289503006 | 7112US | 7112US | AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombin AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome. | AESKULISA® Cenp-B | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 30 | 04250289502993 | 7111US | 7111US | AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 k AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the quantitative and qualitative detection of antibodies against Scl-70 (70 kDa scleroderma antigen) in human serum. The assay is a tool in the differential diagnosis of systemic sclerosis. | AESKULISA® Scl-70 | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 31 | 04250289502986 | 7110US | 7110US | AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant L AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ SS-B for the quantitative and qualitative detection of antibodies against Laantigen / SS-B in human serum. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-B | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 32 | 04250289502979 | 7107US | 7107US | AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qual AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of highly purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies are species-specific (directed against human protein only) and preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-A | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 33 | 04250289502962 | 7106US | 7106US | AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smi AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the quantitative and qualitative detection of antibodies against Sm in human serum. Anti-Sm antibodies recognize specific conformational epitopes only accessible on native human Sm. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE). | AESKULISA® Sm | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 34 | 04250289502955 | 7105US | 7105US | AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and q AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex highly purified from the cell-line HeLa. The U1-snRNP complex comprises the Smith antigen (Sm) and RNPs, the 70kDa U1specific protein plus protein A and C. The assay is a tool for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) | AESKULISA® snRNP-C | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 35 | 04250289502948 | 7104US | 7104US | AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is a tool in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE). | AESKULISA® U1-70 | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 36 | 04250289502931 | 7103US | 7103US | AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquan AESKULISA ENA-6Pro 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 a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ENA-6Pro | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 37 | 04250289502917 | 7101US | 7101US | AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitat AESKULISA ANA-8Pro 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 a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ANA-8Pro | AESKU.DIAGNOSTICS GMBH & CO. KG |
| 38 | 04250289500555 | 3113 | AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histid AESKULISA Jo-1 is a solid phase enzyme immunoassay with recombinant human histidyltRNA-synthetase (HRS) for the quantitative and qualitative detection of antibodies against Jo-1 (named after the prototype patient) in human serum. Human sera with anti-Jo-1 antibodies solely recognize HRS of higher eukaryotes and react with highest affinity with the human enzyme. The assay is a tool in the diagnosis of polymyositis and dermatomyositis. | AESKULISA® Jo-1 | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 39 | 04250289500548 | 3112 | AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombin AESKULISA Cenp-B is a solid phase enzyme immunoassay employing purified recombinant human 80 kDa centromere protein B (Cenp-B) for the quantitative and qualitative detection of IgG antibodies against Cenp-B in human serum. The assay ensures the highest specificity and sensitivity for the detection of antibodies against centromere protein B, which serves as an aid in the diagnosis of systemic sclerosis and CREST syndrome. | AESKULISA® Cenp-B | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 40 | 04250289500531 | 3111 | AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 k AESKULISA Scl-70 is a solid phase enzyme immunoassay with human recombinant 70 kDa fragment of DNA topoisomerase I for the quantitative and qualitative detection of antibodies against Scl-70 (70 kDa scleroderma antigen) in human serum. The assay is a tool in the differential diagnosis of systemic sclerosis. | AESKULISA® Scl-70 | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 41 | 04250289500524 | 3110 | AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant L AESKULISA SS-B is a solid phase enzyme immunoassay employing human recombinant La-antigen/ SS-B for the quantitative and qualitative detection of antibodies against Laantigen / SS-B in human serum. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-B | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 42 | 04250289500494 | 3107 | AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qual AESKULISA SS-A is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against Ro/ SS-A in human serum. The assay employs human Ro/SS-A antigen composed of highly purified native 60kDa and recombinant human 52 kDa Ro/SS-A protein. Anti-SS-A antibodies are species-specific (directed against human protein only) and preferentially react with the native 60kDa molecule where as most antibodies to the 52 kDa protein prefer the denatured molecule. The assay is a tool in the diagnosis of Sjögren`s syndrome (SS) and systemic lupus erythematosus (SLE). | AESKULISA® SS-A | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 43 | 04250289500487 | 3106 | AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smi AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the quantitative and qualitative detection of antibodies against Sm in human serum. Anti-Sm antibodies recognize specific conformational epitopes only accessible on native human Sm. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE). | AESKULISA® Sm | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 44 | 04250289500470 | 3105 | AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and q AESKULISA snRNP-C is a solid phase enzyme immunoassay for the quantitative and qualitative detection of antibodies against the snRNP complex in human serum. The assay employs native human U1-snRNP complex highly purified from the cell-line HeLa. The U1-snRNP complex comprises the Smith antigen (Sm) and RNPs, the 70kDa U1specific protein plus protein A and C. The assay is a tool for the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE) | AESKULISA® snRNP-C | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 45 | 04250289500463 | 3104 | AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human AESKULISA U1-70 is a solid phase enzyme immunoassay employing recombinant human 70 kDa protein of the U1-snRNP complex for the quantitative and qualitative detection of antibodies against the 70 kDa U1-RNP in human serum. The assay is a tool in the diagnosis of mixed connective tissue diseases (MCTD) and systemic lupus erythematosus (SLE). | AESKULISA® U1-70 | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 46 | 04250289500456 | 3103 | AESKULISA ENA-6Pro is a solid phase enzyme immunoassay for the separate semiquan AESKULISA ENA-6Pro 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 a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ENA-6Pro | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 47 | 04250289500425 | 3101 | AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitat AESKULISA ANA-8Pro 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 a tool in the differential diagnosis of systemic rheumatic diseases. | AESKULISA® ANA-8Pro | AESKU.DIAGNOSTICS GMBH & CO. KG | |
| 48 | 04049016124917 | DL 1590-6401-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 49 | 04049016124900 | DL 1590-1601-9 G | EUROLINE ENA Profile 9 Ag (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG | ||
| 50 | 04049016084785 | DL 1590-6401-4 G | EUROLINE ENA ProfilePlus 4 (IgG) | EUROIMMUN MEDIZINISCHE LABORDIAGNOSTIKA AG |