Versant HCV RNA Qualitative Assay

FDA premarket approval P020011 · Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus

PMA numberP020011

Approval

Applicant
Gen-Probe
Received
March 18, 2002
Decision date
November 7, 2002 (APRL)
Supplements
16, latest July 21, 2020
Product code
MZP – Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

Official FDA PMA record

Approval order statement

APPROVAL FOR THE VERSANT HCV RNA QUALITATIVE ASSAY. THE DEVICE IS INDICATED FOR: THE VERSANT HCV RNA QUALITATIVE ASSAY IS AN IN VITRO NUCLEIC ACID AMPLIFICATION ASSAY FOR THE DETECTION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA (EDTA, SODIUM HEPARIN, SODIUM CITRATE, AND ACD) OR SERUM. THE VERSANT HCV RNA QUALITATIVE ASSAY IS INDICATED FOR USE WITH FRESH OR FROZEN SPECIMENS FROM THE FOLLOWING POPULATIONS: INDIVIDUALS WITH ANTIBODY EVIDENCE OF HCV INFECTION WITH EVIDENCE OF LIVER DISEASE, AND INDIVIDUALS SUSPECTED TO BE ACTIVELY INFECTED WITH HCV WITH ANTIBODY EVIDENCE, AND INDIVIDUALS AT RISK FOR HCV INFECTION WITH ANTIBODIES TO HCV. DETECTION OF HCV RNA IS EVIDENCE OF ACTIVE HCV INFECTION.