PMA P050028S083
- Device
- Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S083
- Product code
- MKT
- Decision date
- 2020-08-26
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- Manufacturing process change to use an alternate filter
Current openFDA PMA Record#
- Device
- Roche COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S083
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2020-08-26
- Decision code
- OK30
- Date received
- 2020-07-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process change to use an alternate filter