|
Device | VERSANT HCV RNA QUALITATIVE ASSAY |
Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | GEN-PROBE 10210 GENETIC CENTER DR. SAN DIEGO, CA 92121 |
PMA Number | P020011 |
Supplement Number | S005 |
Date Received | 04/05/2012 |
Decision Date | 06/25/2012 |
Reclassified Date
|
12/22/2021 |
Product Code |
MZP |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A DEVICE NAME CHANGE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VERSANT HCV RNA QUALITATIVE ASSAY AND APTIMA HCV RNA QUALITATIVE ASSAY AND IS INDICATED FOR THE DETECTION OF HEPATITIS C VIRUS (HCV) RNA IN HUMAN PLASMA (EDTA, SODIUM HEPARIN, SODIUM CITRATE, AND ACD) OR SERUM. |