PMA P000012S056
- Device
- COBAS AMPLICOR HCV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S056
- Product code
- MZP
- Decision date
- 2016-08-04
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- Addition of a new fermenter used in the manufacturing process for enzymes.
Current openFDA PMA Record
- Device
- COBAS AMPLICOR HCV
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S056
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2016-08-04
- Decision code
- OK30
- Date received
- 2016-07-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new fermenter used in the manufacturing process for enzymes.