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U.S. Department of Health and Human Services

Product Classification

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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.
Physical State n/a
Technical Method An enzyme linked immunosorbent assay (ELISA) for the detection of 11dhTxB2.
Target Area n/a
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeOBW
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.5700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible