PMA P020011S005
- Device
- VERSANT HCV RNA QUALITATIVE ASSAY
- Applicant
- Gen-Probe
- PMA number
- P020011
- Supplement
- S005
- Product code
- MZP
- Decision date
- 2012-06-25
- Classification
- Assay, Hybridization And/or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,hepatitis C Virus
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- 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.
Current openFDA PMA Record#
- Device
- VERSANT HCV RNA QUALITATIVE ASSAY
- Applicant
- Gen-Probe
- PMA number
- P020011
- Supplement
- S005
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2012-06-25
- Decision code
- APPR
- Date received
- 2012-04-05
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.