Identity
- Trade Name
- REAADS Protein C Test Kit FDA UDI
- Generic Name
- Protein C IVD, kit, chromogenic FDA UDI
- Device Name
- INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Protein C Antigen in citrated human plasma. For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE TEST Protein C deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. Patients with a congenital heterozygous deficiency may present with venous thrombosis in young adulthood, while patients with the rare homozygous deficiency present with massive thrombosis (purpura fulminans) during the neonatal period. The prevalence of Protein C deficiency in the general population has been estimated at 1 in 300. In younger patients (<40-45 years) with recurrent venous thrombosis, the frequency of Protein C deficiencies may be as high as 10 to 15%. A decreased Protein C activity in plasma may be the result of low concentrations and function (type I) or only low function (type II). PRINCIPLE OF THE TEST The Protein C Antigen assay is a sandwich ELISA. A capture antibody specific for human Protein C is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available Protein C to bind to the anti-human Protein C antibody on the microwell surface. The plates are washed to remove unbound proteins and other plasma molecules. Bound Protein C is quantitated using horseradish peroxidase (HRP) conjugated anti-human Protein C 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. Protein C Antigen relative percent concentrations in patient plasma are determined against a curve prepared from the reference plasma provided with the kit. Refer to Product Package Insert. FDA UDI
- Model / Reference
- 035-001 FDA UDI
- Description
- INTENDED USE An enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Protein C Antigen in citrated human plasma. For In Vitro Diagnostic Use. SUMMARY AND EXPLANATION OF THE TEST Protein C deficiency, either congenital or acquired, may lead to serious thrombotic events such as thrombophlebitis, deep vein thrombosis, or pulmonary embolism. Patients with a congenital heterozygous deficiency may present with venous thrombosis in young adulthood, while patients with the rare homozygous deficiency present with massive thrombosis (purpura fulminans) during the neonatal period. The prevalence of Protein C deficiency in the general population has been estimated at 1 in 300. In younger patients (<40-45 years) with recurrent venous thrombosis, the frequency of Protein C deficiencies may be as high as 10 to 15%. A decreased Protein C activity in plasma may be the result of low concentrations and function (type I) or only low function (type II). PRINCIPLE OF THE TEST The Protein C Antigen assay is a sandwich ELISA. A capture antibody specific for human Protein C is coated to 96-microwell polystyrene plates. Diluted patient plasma is incubated in the wells, allowing any available Protein C to bind to the anti-human Protein C antibody on the microwell surface. The plates are washed to remove unbound proteins and other plasma molecules. Bound Protein C is quantitated using horseradish peroxidase (HRP) conjugated anti-human Protein C 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. Protein C Antigen relative percent concentrations in patient plasma are determined against a curve prepared from the reference plasma provided with the kit. Refer to Product Package Insert. FDA UDI
Identifiers
- Catalog Number
- 035-001 FDA UDI
- Primary DI / UDI-DI
- 00855360006021 FDA UDI
- 510(k) Number
- K972342 FDA UDI
- FDA Product Code
- GGP FDA UDI
- GMDN Term
- Protein C IVD, kit, chromogenic FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7290 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Protein C IVD, kit, chromogenic
REAADS Protein C Test Kit by Corgenix Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K972342 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Corgenix Medical Corporation
Sources (1)
- FDA UDI d1ecd4f4-d7c7-4189-bbd9-f620e635751d 37 fields · synced May 30, 2026