Identity
- Trade Name
- 11dhTxB2 Test Kit (11-Dehydro Thromboxane B2) FDA UDI
- Generic Name
- Thromboxane IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- INTENDED USE The 11dhTxB2 Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine which aids in the qualitative detection of acetylsalicylic acid (ASA) effect in apparently healthy individuals post ingestion. For In Vitro Diagnostic Use. SUMMARY OF THE ASSAY Activated platelets produce Thromboxane A2 (TxA2), a potent vasoconstrictor and inducer of platelet aggregation. TxA2 is generated by Thromboxane synthase from molecules derived from arachidonic acid by cyclooxygenase-1 (COX-1). TxA2 has a short half-life in plasma and is rapidly hydrolyzed to Thromboxane B2 (TxB2). TxB2, in turn, is metabolized to 11-Dehydro Thromboxane B2 (11dhTxB2).The measurement of stable metabolites of TxA2, such as urinary11dhTxB2, is a means of quantitating TxA2 production in vivo and thus a direct way to analyze ASA’s effect post ingestion. PRINCIPLE OF THE TEST The 11dhTxB2 Test Kit measures urinary 11dhTxB2 and is performed as a competitive ELISA. Diluted samples (Reference Solution, controls, and patient urine), purified 11dhTxB2 conjugated to alkaline phosphatase (AP), and purified mouse monoclonal antibody directed to 11dhTxB2 are combined and incubated in microwells coated with a polyclonal anti-mouse antibody. The monoclonal antibody then binds to the polyclonal anti-mouse antibody coated on the microtiter plate. After the removal of unbound complexes by washing, the bound AP-11dhTxB2 conjugate is assayed by the addition of para-nitrophenylphosphate (pNPP) chromogenic substrate. Color develops in the wells at an intensity inversely proportional to the sample urine concentration of 11dhTxB2, and is read at 405nm. Results (pg/mL) are calculated against a reference curve prepared from the Reference Solution provided in the kit. Final results are reported as pg 11dhTxB2 per mg creatinine to normalize results for urine concentration. Refer to product package insert. FDA UDI
- Model / Reference
- 12136 FDA UDI
- Description
- INTENDED USE The 11dhTxB2 Test Kit is an enzyme-linked immunoassay (ELISA) to determine levels of 11-Dehydro Thromboxane B2 (11dhTxB2) in human urine which aids in the qualitative detection of acetylsalicylic acid (ASA) effect in apparently healthy individuals post ingestion. For In Vitro Diagnostic Use. SUMMARY OF THE ASSAY Activated platelets produce Thromboxane A2 (TxA2), a potent vasoconstrictor and inducer of platelet aggregation. TxA2 is generated by Thromboxane synthase from molecules derived from arachidonic acid by cyclooxygenase-1 (COX-1). TxA2 has a short half-life in plasma and is rapidly hydrolyzed to Thromboxane B2 (TxB2). TxB2, in turn, is metabolized to 11-Dehydro Thromboxane B2 (11dhTxB2).The measurement of stable metabolites of TxA2, such as urinary11dhTxB2, is a means of quantitating TxA2 production in vivo and thus a direct way to analyze ASA’s effect post ingestion. PRINCIPLE OF THE TEST The 11dhTxB2 Test Kit measures urinary 11dhTxB2 and is performed as a competitive ELISA. Diluted samples (Reference Solution, controls, and patient urine), purified 11dhTxB2 conjugated to alkaline phosphatase (AP), and purified mouse monoclonal antibody directed to 11dhTxB2 are combined and incubated in microwells coated with a polyclonal anti-mouse antibody. The monoclonal antibody then binds to the polyclonal anti-mouse antibody coated on the microtiter plate. After the removal of unbound complexes by washing, the bound AP-11dhTxB2 conjugate is assayed by the addition of para-nitrophenylphosphate (pNPP) chromogenic substrate. Color develops in the wells at an intensity inversely proportional to the sample urine concentration of 11dhTxB2, and is read at 405nm. Results (pg/mL) are calculated against a reference curve prepared from the Reference Solution provided in the kit. Final results are reported as pg 11dhTxB2 per mg creatinine to normalize results for urine concentration. Refer to product package insert. FDA UDI
Identifiers
- Catalog Number
- 12136 FDA UDI
- Primary DI / UDI-DI
- 00855360006274 FDA UDI
- 510(k) Number
- K062025 FDA UDI
- FDA Product Code
- OBW FDA UDI
- GMDN Term
- Thromboxane IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.5700 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: Thromboxane IVD, kit, enzyme immunoassay (EIA)
11dhTxB2 Test Kit (11-Dehydro Thromboxane B2) 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 01a01a7a-ac05-4ad6-9ceb-d1fa7aaf9897 37 fields · synced May 30, 2026