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U.S. Department of Health and Human Services

Product Classification

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Device test, factor v leiden mutations, genomic dna pcr
Regulation Description Factor V Leiden DNA mutation detection systems.
Definition In vitro diagnostic test to detect the Factor V Leiden mutation in genomic DNA, as an aid to diagnosis in the evaluation of patients with suspected thrombophilia.
Regulation Medical Specialty Hematology
Review Panel Pathology
Product CodeNPQ
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Division of Molecular Genetics and Pathology (DMGP)
Submission Type 510(k)
Regulation Number 864.7280
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
Recognized Consensus Standard
Third Party Review Not Third Party Eligible
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