OBW

11-Dehydro Thromboxane B2 Kit, Urinary

Product code

OBW

Device name

11-Dehydro Thromboxane B2 Kit, Urinary

Device class

Class 2

21 CFR

21 CFR 864.5700

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).