Product code OBW

Device name
11-Dehydro Thromboxane B2 Kit, Urinary
Medical specialty
Hematology
Device class
2
Regulation number
864.5700
Review panel
HE
Implant
N
Life sustaining/supporting
N
GMP exempt
N
Third party review
Y
Summary malfunction reporting
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.
Source
FDA openFDA device classification dataset