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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)
Division of Immunology and Hematology Devices (DIHD)
Submission Type 510(k)
Regulation Number 864.5700
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting
Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review
Accredited Persons
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