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U.S. Department of Health and Human Services

Product Classification

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Device test, heparin neutralization
Regulation Description Heparin assay.
Regulation Medical Specialty Hematology
Review Panel Hematology
Product CodeJBR
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type 510(k)
Regulation Number 864.7525
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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