DeviceClearance

Product code OBW— Hematology

ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136

Classification name
11-Dehydro Thromboxane B2 Kit, Urinary
Device class
Class 2
Regulation
21 CFR 864.5700
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OBW under 21 CFR 864.5700, via openFDA

Market context for product code OBW

FDA has cleared 1 device under product code OBW, all in 2007, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OBW

Recent clearances under product code OBW

Data sourced from openFDA. This site is unofficial and independent of the FDA.