PMA P000012S055
- Device
- Cobas Amplicor (tm) Hepatitis C Virus (hcv) Test,
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S055
- Decision date
- 2016-05-13
Current openFDA PMA Record
- Device
- COBAS AMPLICOR (TM) HEPATITIS C VIRUS (HCV) TEST, V2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S055
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2016-05-13
- Decision code
- OK30
- Date received
- 2016-04-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new filler system and transfer of the microtube filling operations of controls to a new laboratory.