| Primary Device ID | 00855360006038 |
| NIH Device Record Key | 3ad402d2-01c4-4755-9366-e9d5973bd444 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | REAADS von Willebrand Factor Antigen Test Kit |
| Version Model Number | 034-001 |
| Catalog Number | 034-001 |
| 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 |
| 00855360006007 - REAADS Protein S Antigen Test kit | 2018-07-06 INTENDED USE
An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Total and Free Protein S Antigen |
| 00855360006014 - REAADS Monoclonal Free Protein S Antigen | 2018-07-06 INTENDED USE
An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Free Protein S Antigen in citrat |
| 00855360006021 - REAADS Protein C Test Kit | 2018-07-06 INTENDED USE
An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Protein C Antigen in citrated hu |
| 00855360006038 - REAADS von Willebrand Factor Antigen Test Kit | 2018-07-06INTENDED USE
An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand
Factor Antigen (VWF: Ag) in citrated human plasma. For In Vitro Diagnostic Use.
SUMMARY THE TEST
Von Willebrand Factor Antigen (VWF:Ag or Factor VIII-related protein) is a plasma protein found in
circulation combined by non-covalent interactions with Factor VIII (FVIII:C), a pro-coagulant protein also
known as the anti-hemophilic factor. These two proteins show distinct biochemical and functional
properties as well as different antigenic determinants; their plasma levels may vary independently of
each other. Deficiency of FVIII causes classic hemophilia while deficiency of VWF causes Von
Willebrand disease.
VWF:Ag plays a very important role in hemostasis. The prevalence of Von Willebrand disease has been estimated to be 1-3% of the
general population. Approximately 80% of Von Willebrand disease patients have a type I deficiency.
The laboratory diagnosis of Von Willebrand disease may require both quantitative and qualitative
(functional) determinations.
PRINCIPLE OF THE TEST
REAADS VWF:Ag assay is a sandwich ELISA. A capture antibody specific for human VWF is coated to
96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available
VWF:Ag to bind to the anti-human VWF antibody on the microwell surface. The plates are washed to
remove unbound proteins and other plasma molecules. Bound VWF:Ag is quantitated using horseradish
peroxidase (HRP) conjugated anti-human VWF detection antibody. Following incubation, unbound
conjugate is removed by washing. A chromogenic substrate of tetramethylbenzidine (TMB) and hydrogen
peroxide (H2O2) is added to develop a colored reaction. The intensity of the color is measured in optical
density (O.D.) units with a spectrophotometer at 450nm. Patient VWF:Ag in relative percent
concentration is determined against a curve made from the reference plasma provided with the kit. Refer to product package insert. |
| 00855360006038 - REAADS von Willebrand Factor Antigen Test Kit | 2018-07-06 INTENDED USE
An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Von Willebrand
Factor Antigen (V |
| 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 |