PMA P050028S085
- Device
- COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S085
- Product code
- MKT
- Decision date
- 2021-08-11
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Change the manufacturer/supplier of a critical sub-assembly component.
Current openFDA PMA Record#
- Device
- COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S085
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2021-08-11
- Decision code
- OK30
- Date received
- 2021-06-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the manufacturer/supplier of a critical sub-assembly component.