PMA P000012S034
- Device
- COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S034
- Product code
- MZP
- Decision date
- 2011-09-29
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- APPROVAL FOR THE REVISION OF THE PACKAGE INSERT FOR THE COBAS AMPIPREP/COBAS AMPLICOR HCV TEST, V2.0.
Current openFDA PMA Record
- Device
- COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S034
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2011-09-29
- Decision code
- APPR
- Date received
- 2011-09-01
- Supplement type
- Special (Immediate Track)
- Approval order statement
- APPROVAL FOR THE REVISION OF THE PACKAGE INSERT FOR THE COBAS AMPIPREP/COBAS AMPLICOR HCV TEST, V2.0.