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U.S. Department of Health and Human Services

Product Classification

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Device assay, genotyping, hepatitis c virus
Definition In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant hepatitis c virus rna genotypes.
Physical State RT-PCR amplification
Technical Method In vitro diagnostic device for qualitative detection and classification of 8 clinically relevant Hepatitis C Virus RNA genotypes
Target Area Human specimens
Review Panel Microbiology
Product CodeOBF
Premarket Review Office of In Vitro Diagnostics and Radiological Health (OIR)
Submission Type PMA
Device Class 3
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
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