PMA P050028S093
- Device
- COBAS AmpliPrep/ COBAS TaqMan HBV Test, v 2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S093
- Product code
- MKT
- Decision date
- 2024-09-11
- Classification
- Microbiology
- Generic name
- Hepatitis Viral B DNA Detection
- Approval order statement
- a change in filtration and the discontinuation of environmental monitoring during manufacture of a kit component
Current openFDA PMA Record#
- Device
- COBAS AmpliPrep/ COBAS TaqMan HBV Test, v 2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S093
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2024-09-11
- Decision code
- OK30
- Date received
- 2024-08-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in filtration and the discontinuation of environmental monitoring during manufacture of a kit component