| Primary Device ID | 00855360006113 |
| NIH Device Record Key | a67851b4-612e-41f7-8d99-18275fb07ea6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well) |
| Version Model Number | 13534 |
| Catalog Number | 13534 |
| 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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| 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
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| 00855360006083 - Corgenix Anti-Cardiolipin IgA Semi-Quantitative Test Kit (192 Well) | 2018-07-06 INTENDED USE
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| 00855360006113 - Corgenix Anti-Phosphatidylserine IgG Semi-Quantitative Test Kit (192 Well) | 2018-07-06INTENDED 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 TEST
The 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 IgG, 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 IgG anti-phosphatidylserine antibody concentrations expressed in GPS (IgG 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. |
| 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 |