PMA P060030S085
- Device
- COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P060030
- Supplement
- S085
- Product code
- MZP
- Decision date
- 2021-03-09
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Approval order statement
- Move the manufacturing site of critical sub-assembly.
Current openFDA PMA Record#
- Device
- COBAS AmpliPrep/COBAS TaqMan HCV Test v2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P060030
- Supplement
- S085
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2021-03-09
- Decision code
- OK30
- Date received
- 2021-02-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Move the manufacturing site of critical sub-assembly.