PMA P000010S025
- Device
- Amplicor Hcv Test V2.0 & Cobas Amplicor Hcv Test V
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000010
- Supplement
- S025
- Decision date
- 2011-10-11
Current openFDA PMA Record
- Device
- AMPLICOR HCV TEST V2.0 & COBAS AMPLICOR HCV TEST V2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000010
- Supplement
- S025
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2011-10-11
- Decision code
- OK30
- Date received
- 2011-09-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE ROOM LOCATION AND EQUIPMENT FOR FILLING AND LABELING OF CERTAIN VIALED INTERMEDIATE COMPONENTS.