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11-Dehydro Thromboxane B2 Kit, Urinary

FDA product code OBW · 1 cleared devices

Class 2 Hematology
Regulation
21 CFR 864.5700
Review panel
HE
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2007-05-29 – 2007-05-29

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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