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U.S. Department of Health and Human Services

Product Classification
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Device test, factor ii g20210a mutations, genomic dna pcr
Regulation Description Factor V Leiden DNA mutation detection systems.
Definition In vitro diagnostic test to detect the Factor II G20210A 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 CodeNPR
Premarket Review Office of In Vitro Diagnostics (OHT7)
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
Third Party Review Not Third Party Eligible
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