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REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit FDA UDI
- Generic Name
- Prothrombin antibody (anti-prothrombin) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- 10238 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- 10238 FDA UDI
- Primary DI / UDI-DI
- 00855360006212 FDA UDI
- FDA Product Code
- DHC FDA UDI
- GMDN Term
- Prothrombin antibody (anti-prothrombin) IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5820 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: Prothrombin antibody (anti-prothrombin) IVD, kit, enzyme immunoassay (EIA)
REAADS IgG Anti-Prothrombin Semi-Quantitative Test Kit by Corgenix Medical Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 8fd46f7d-41d3-4e2d-a6df-cc94cb0c82cd 36 fields · synced Jun 1, 2026