No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00816057021192 | NC-909001 | NC-909001 | Detection of Syphilis | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI Disposible Stirrer Pipet |
2 | 00816057021185 | NC-5071-002-500 | NC-5071-002-500 | Disposable Pipet, 500/bag | GTO | Anti-Streptokinase | 1 | ASI Disposible Stirrer Pipet |
3 | 00816057021123 | NC-987X30LCA | NC-987X30LCA | Detection of Syphilis, 30 Well, Cutsom | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
4 | 00816057021116 | NC-987X30 | NC-987X30 | Detection of Syphilis, 30 Well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
5 | 00816057021109 | NC-987X15 | NC-987X15 | Detection of Syphilis, 15 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
6 | 00816057021093 | NC-987X10E | NC-987X10E | Detection of Syphilis, 10 well, Export | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
7 | 00816057021086 | NC-987530LCA | NC-987530LCA | Detection of Syphilis, 30 well, custom | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
8 | 00816057021079 | NC-987530E | NC-987530E | Detection of Syphilis, 30 well, Export | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
9 | 00816057021062 | NC-987530 | NC-987530 | Detection of Syphilis, 30 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
10 | 00816057021055 | NC-987515 | NC-987515 | Detection of Syphilis, 15 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
11 | 00816057021048 | NC-987510LCA | NC-987510LCA | Detection of Syphilis, no controls, 10 well, custom | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
12 | 00816057021031 | NC-987510 | NC-987510 | Detection of Syphilis, no controls, 10 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
13 | 00816057021017 | NC-987110LCA | NC-987110LCA | Detection of Syphilis, no controls, custom | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
14 | 00816057021000 | NC-987110 | NC-987110 | Detection of Syphilis, no controls | ASI RPR Card Test for Syphilis | |||
15 | 00816057020881 | NC-90010000-30 | NC-90010000-30 | Detection of Syphilis, 30 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
16 | 00816057020874 | NC-90010000-10 | NC-90010000-10 | Detection of Syphilis, 10 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
17 | 00816057020867 | NC-9005000-30T | NC-9005000-30T | Detection of Syphilis, 30 Well, TDH | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
18 | 00816057020850 | NC-9005000-30E | NC-9005000-30E | Detection of Syphilis, Export, 30 Well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
19 | 00816057020843 | NC-9005000-30 | NC-9005000-30 | Detection of Syphilis, 30 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
20 | 00816057020836 | NC-9005000-10T | NC-9005000-10T | Detection of Syphilis, 10 well, TDH | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
21 | 00816057020812 | NC-9005000-10 | NC-9005000-10 | Detection of Syphilis, 10 well | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
22 | 00816057020805 | NC-900500T | NC-900500T | Detection of Syphilis, TDH | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
23 | 00816057020799 | NC-900500E | NC-900500E | Detection of Syphilis, Export | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
24 | 00816057020782 | NC-900500-NYE | NC-900500-NYE | Detection of Syphilis, Export, 3x3ml | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
25 | 00816057020775 | NC-900500-NEO | NC-900500-NEO | Detection for Syphilis, Export, No Controls | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
26 | 00816057020768 | NC-900500-FD | NC-900500-FD | Detection of Syphilis, Export (French) | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
27 | 00816057020751 | NC-900500 | NC-900500 | Syphilis screening test - Nontreponemal | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
28 | 00816057020744 | NC-900100E | NC-900100E | Detection of Syphilis, Export | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
29 | 00816057020720 | NC-900100-FD | NC900100-FD | Detection of Syphilis, Export (French) | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
30 | 00816057020713 | NC-900100 | NC-900100 | Detection of Syphilis | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
31 | 00816057020706 | NC-900025E | NC-900025E | Syphilis Screening Test, Export | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
32 | 00816057020690 | NC-900025 | NC-900025 | Syphilis Screening Test | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Card Test for Syphilis |
33 | 00816057020614 | NC-860096-AG | NC-860096-AG | Detection of Mumps antibody | LJY | Enzyme Linked Immunoabsorbent Assay, Mumps Virus | 1 | ASI Mumps IgG EIA Test |
34 | 00816057020577 | NC-830096-AG | NC-830096-AG | Detection of Herpes Simplex 1 and 2 Antibodies | LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 | ASI HSV IgG EIA Test |
35 | 00816057020515 | NC-800096-AG | NC-800096-AG | Detection of Rubella Virus Antiboby | LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | ASI Rubella IgG EIA Test |
36 | 00816057021642 | NC-705001 | NC705001 | Detection of Rheumatoid Factor | DHR | System, Test, Rheumatoid Factor | 2 | ASI RF Direct Slide Test Control Set |
37 | 00816057021628 | NC-505001 | NC-505001 | Detection of C-Reactive Protein | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Control Set |
38 | 00816057021253 | NC-909002 | NC-909002 | Detection of Syphilis | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Dispensing Bottle |
39 | 00816057021246 | NC-90900210 | NC-90900210 | Detection of Syphilis | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Dispensing Bottle |
40 | 00816057021239 | NC-5072-002 | NC-5072-002 | Blunt, 20 gauge needle cover | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI RPR Dropper Needle Cover |
41 | 00816057020997 | NC-907132 | NC-907132 | Detection of Syphilis | GMP | Antisera, Control For Nontreponemal Tests | 2 | ASI Syphilis Reference Sera |
42 | 00816057020638 | NC-870096-AG | NC-870096-AG | Detection of Epstein Barr Nuclear Antigen | LSE | Epstein-Barr Virus, Other | 1 | ASI EBNA IgG EIA Test |
43 | 00816057020539 | NC-810096-AG | NC-810096-AG | Detection of Toxoplasma Antibody | LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | ASI Toxoplasma IgG EIA Test |
44 | 00816057020393 | NC-5001000 | NC-5001000 | Detection of C-Reactive Protein | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
45 | 00816057020386 | NC-500100E | NC-500100E | Detection of C-Reactive Protein, Export | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
46 | 00816057020379 | NC-500100 | NC-500100 | Detection of C-Reactive Protein | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
47 | 00816057020362 | NC-500050E | NC-500050E | Detection of C-Reactive Protein, Export | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
48 | 00816057020355 | NC-500050 | NC-500050 | Detection of C-Reactive Protein | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
49 | 00816057020348 | NC-500025E | NC-500025E | Detection of C-Reactive Protein, Export | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
50 | 00816057020331 | NC-500025 | NC-500025 | Detection of C-Reactive Protein | DCN | System, Test, C-Reactive Protein | 2 | ASI CRP Slide Test |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00855360006212 | 10238 | 10238 | INTENDED USE For the detection and semi-quantitation of IgG anti-prothrombin (aP INTENDED USE For the detection and semi-quantitation of IgG anti-prothrombin (aPT) antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (e.g., antiphospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY OF THE TEST Antiphospholipid antibodies are a heterogeneous group of immunoglobulins (IgG, IgM, IgA) that bind to several anionic phospholipids (e.g., cardiolipin, phosphatidylserine), to phospholipid-protein complexes, and to certain proteins in the absence of anionic phospholipids. The REAADS aPT ELISA test kit uses purified human prothrombin as antigen to detect IgG anti-prothrombin antibodies in human serum or citrated plasma in the absence of other exogenous cofactors or phospholipids. High serum or plasma levels of aPT antibodies may add valuable information in the laboratory assessment of antiphospholipid antibodies.PRINCIPLE OF THE TEST The test is an indirect ELISA. Diluted serum/citrated plasma samples, calibrators and controls are incubated in microwells coated with purified human prothrombin. After the removal of unbound proteins by washing, antibodies specific for human IgG labeled with horseradish peroxidase (HRP) are added forming complexes with the prothrombin bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. Color develops in the wells. Results are obtained by reading the O.D. of each test well in a spectrophotometer. Calibrator sera are provided with the IgG anti-prothrombin antibody concentration. The user will run a single point calibration, dividing the concentration value of the calibrator sera by the O.D. value of the calibrator providing a conversion factor. The O.D. values of the other samples are multiplied by the conversion factor to obtain IgG anti-prothrombin antibody concentrations in G units. Refer to Product Package Insert. | REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit | CORGENIX MEDICAL CORPORATION |
2 | 00855360006137 | 13535 | 13535 | INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodi INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (i.e., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells. β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum/ plasma proteins by washing, antibodies specific for human IgM, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Following another washing 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-phosphatidylserine (aPS) antibodies. Results are obtained by reading the Optical Density of each well in a spectrophotometer. Calibrator sera are provided with the IgM anti-phosphatidylserine antibody concentrations expressed in MPS (IgM aPS) units traceable to the reference preparations of the Louisville Antiphospholipid Laboratory Control and patient results are determined from the calibration curve. Refer to Package Insert. | Corgenix Anti-Phosphatidylserine IgM Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
3 | 00855360006120 | 13536 | 13536 | INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodi INTENDED USE Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythematosus (SLE) and lupus-like disorders (anti-phospholipid syndrome). For In Vitro Diagnostic Use.SUMMARY AND EXPLANATION OF THE TEST High serum levels of anti-phospholipid antibodies are frequently detected in patients with autoimmune (i.e., SLE) and non-autoimmune diseases, as well as in apparently healthy individuals. These antibodies have been associated with an increased risk for recurrent arterial and venous thrombotic events, thrombocytopenia and fetal loss. Phosphatidylserine is a more physiologically relevant phospholipid due to its presence in cell membranes of endothelial cells and platelets.PRINCIPLE OF THE TESTThe test is an indirect ELISA. Diluted serum/plasma samples, calibrator sera, and controls are incubated in phosphatidylserine coated microwells.β2-glycoprotein I is provided in the sample diluent. After the removal of unbound serum/ plasma proteins by washing, antibodies specific for human IgA, labeled with horseradish peroxidase (HRP), are added forming complexes with the phosphatidylserine bound antibodies. Following another washing 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-phosphatidylserine (aPS) antibodies. Results are obtained by reading the Optical density of each well in a spectrophotometer. Calibrator sera are provided with the IgA anti-phosphatidylserine antibody concentrations expressed in APS (IgA aPS) units traceable to the reference preparations of the Louisville Antiphospholipid Laboratory Control and patient results are determined from the calibration curve. Refer to Package Insert. | Corgenix Anti-Phosphatidylserine IgA Semi-Quantitative Test Kit (192 Well) | CORGENIX MEDICAL CORPORATION |
4 | 00847817018282 | 425-2160 | 425-2160 | Autoimmune EIA Anti-Phosphatidylserine IgA Test Kit | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
5 | 00847817018275 | 425-2140 | 425-2140 | Autoimmune EIA Anti-Phosphatidylserine IgM Test Kit | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
6 | 00847817018268 | 425-2120 | 425-2120 | Autoimmune EIA Anti-Phosphatidylserine IgG Test | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
7 | 00847817018251 | 425-2100 | 425-2100 | Autoimmune EIA Anti-ß2 Glycoprotein I IgA Test Kit | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
8 | 00847817018244 | 425-2080 | 425-2080 | Autoimmune EIA Anti-?2 Glycoprotein I IgM Test Kit | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
9 | 00847817018237 | 425-2060 | 425-2060 | Autoimmune EIA Anti-ß2 Glycoprotein I IgG Test Kit | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
10 | 00847817018220 | 425-2040 | 425-2040 | Autoimmune EIA Anti-Cardiolipin IgA Test Kit | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
11 | 00847817018213 | 425-2020 | 425-2020 | Autoimmune EIA Anti-Cardiolipin IgM Test Kit | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
12 | 00847817018206 | 425-2000 | 425-2000 | Autoimmune EIA Anti-Cardiolipin IgG Test Kit | Autoimmune EIA | BIO-RAD LABORATORIES, INC. |
13 | 00816057021604 | NC-355001 | NC355001 | Detection of Asnti-DNP, associated with Systemis Lupus Erythematosus | ASI SLE Slide Test Control Set | ARLINGTON SCIENTIFIC, INC. |
14 | 00816057020256 | NC-3501000 | NC-3501000 | Detection of Anti-DNP, associated with Systemic Lupus Erythematosus | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. |
15 | 00816057020249 | NC-350100E | NC350100E | Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. |
16 | 00816057020232 | NC-350100 | NC-350100 | Detection of Anti-DNP, associated with Systemic Lupus Erythematosus | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. |
17 | 00816057020225 | NC-350050E | NC-350050E | Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. |
18 | 00816057020218 | NC-350050 | NC-350050 | Detection of Anti-DNP, associated with Systemic Lupus Erythematosus | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. |
19 | 00816057020201 | NC-350025E | NC-350025E | Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. |
20 | 00816057020195 | NC-350025 | NC-350025 | Detection of Anti-DNP, associated with Systemic Lupus Erythematosus | ASI SLE Slide Test | ARLINGTON SCIENTIFIC, INC. |
21 | 00813545026943 | 2001-192 | 2001-192 | A-nDNA-A Crithidia luciliae 192 Test Kit | MeDiCa | SCIMEDX CORPORATION |
22 | 00813545026936 | 2001-96 | 2001-96 | A-nDNA-A Crithidia luciliae 96 Test Kit | MeDiCa | SCIMEDX CORPORATION |
23 | 00813545026929 | 2001-48 | 2001-48 | A-nDNA-A Crithidia luciliae 48 Test Kit | MeDiCa | SCIMEDX CORPORATION |
24 | 00813545026592 | 0202 | 0202 | Crithidia luciliae 8 Well Slide (each) | MeDiCa | SCIMEDX CORPORATION |
25 | 00813545026585 | 0201 | 0201 | Crithidia luciliae 4 Well Slide (each) | MeDiCa | SCIMEDX CORPORATION |
26 | 10722355001729 | SLE-100 | A rapid undiluted latex agglutination slide test for the detection of anti-nucle A rapid undiluted latex agglutination slide test for the detection of anti-nucleoprotein serum factors associated with systemic lupus erythematosus (sLE) | Detector Lex SLE | IMMUNOSTICS COMPANY, INC | |
27 | 10722355001712 | SLE-50 | A rapid undiluted latex agglutination slide test for the detection of anti-nucle A rapid undiluted latex agglutination slide test for the detection of anti-nucleoprotein serum factors associated with systemic lupus erythematosus (sLE) | Detector Lex SLE | IMMUNOSTICS COMPANY, INC |