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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device 11-dehydro thromboxane b2 kit, urinary
Regulation Description Automated platelet aggregation system.
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.
Product CodeOBW
Regulation Number 864.5700
Device Class 2

Device Problems
Improper or incorrect procedure or method 1
Total Device Problems 1