OBW
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- 11-Dehydro Thromboxane B2 Kit, Urinary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5700
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- FDA definition
- The 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 aspirin effect in apparently healthy individuals post ingestion. For professional use only.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136 (K062025) | Corgenix, Inc. | 2007-05-29 | + Add |
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