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FDA product code OBW

11-Dehydro Thromboxane B2 Kit, Urinary

HematologyClass 221 CFR 864.5700
Verified
US regulatory classifications
US Product Code (FDA)
OBW
View Product Code Classification
US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 864.5700
View CFR Regulation
Medical specialty
Hematology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Eligible
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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01Thromboxane test02Urinary test03Diagnostic kit04Prostaglandin test05Cardiovascular test06Inflammation test07Lab kit08Diagnostic assay09Immunoassay10Urine analysis
About this record

11-Dehydro Thromboxane B2 Kit, Urinary is a medical device type in the Hematology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.