PMA P000010
- Device
- Amplicor Hcv Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000010
- Supplement
- S024
- Decision date
- 2012-01-11
Current openFDA PMA Record
- Device
- AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000010
- Supplement
- S024
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2012-01-11
- Decision code
- APPR
- Date received
- 2011-07-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE TEST METHOD FOR DETERMINATION OF DITHIOTHREITOL IN BULK AND VIALED LYSIS REAGENTS.