PMA P000012S024
- Device
- COBAS AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S024
- Product code
- MZP
- Decision date
- 2010-03-24
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- CLEAN IN PLACE (CIP) CYCLE CHANGES AND MINOR EQUIPMENT MODIFICATIONS FOR THE SCALE BULK FORMULATION TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINES.
Current openFDA PMA Record
- Device
- COBAS AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- 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
- 2010-03-24
- Decision code
- OK30
- Date received
- 2010-03-01
- Supplement type
- 30-Day Notice
- Approval order statement
- CLEAN IN PLACE (CIP) CYCLE CHANGES AND MINOR EQUIPMENT MODIFICATIONS FOR THE SCALE BULK FORMULATION TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINES.