| Primary Device ID | 00855360006069 |
| NIH Device Record Key | b49f6a67-1314-434f-a526-1e1778b575b8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well) |
| Version Model Number | 13525 |
| Catalog Number | 13525 |
| Company DUNS | 619834542 |
| Company Name | CORGENIX MEDICAL CORPORATION |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
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An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Total and Free Protein S Antigen |
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| 00855360006069 - Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well) | 2018-07-06INTENDED USE
For the detection and semi-quantitation of anti-cardiolipin 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
Anti-phospholipid antibodies are auto antibodies that react with most negatively charged phospholipids, including cardiolipin (CL). Anti-cardiolipin (aCL) antibodies are frequently found in patients with systemic lupus erythematosus (SLE). Elevated levels of aCL antibodies have been reported to be significantly associated with the presence of both venous and arterial thrombosis, thrombocytopenia, and recurrent fetal loss. The term “anti-phospholipid syndrome” (APS) has been introduced to describe patients who present these clinical manifestations.
PRINCIPLE OF THE TEST
The test is an indirect ELISA. Diluted serum samples, calibrator sera, and controls are incubated in cardiolipin coated microwells, allowing aCL antibodies present in the samples to react with the immobilized antigen. After removal of unbound serum proteins by washing, antibodies specific for human IgG labeled with horseradish peroxidase (HRP) are added forming complexes with the cardiolipin bound antibodies. Following another wash step, 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 aCL antibodies.
Results are obtained by reading the O.D. of each well with a spectrophotometer. Calibrator sera are provided, with the IgG aCL concentrations expressed in GPL units. One GPL unit is equivalent to 1 μg/mL of an affinity purified standard IgG sample. Control and patient results are determined from the calibration curve. Refer to Package Insert. |
| 00855360006069 - Corgenix Anti-Cardiolipin IgG Semi-Quantitative Test Kit (192 Well) | 2018-07-06 INTENDED USE
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythema |
| 00855360006076 - Corgenix Anti-Cardiolipin IgM Semi-Quantitative Test Kit (192 Well) | 2018-07-06 INTENDED USE
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythema |
| 00855360006083 - Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well) | 2018-07-06 INTENDED USE
For the detection and semi-quantitation of anti-cardiolipin antibodies in individuals with systemic lupus erythema |
| 00855360006113 - Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well) | 2018-07-06 INTENDED USE
Detection and semi-quantitation of anti-phosphatidylserine antibodies in individuals with systemic lupus erythemat |