- Device
- COBAS® TaqMan® HBV Test for Use with the High Pure System and COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S082
- Product code
- MKT
- Generic name
- Hepatitis Viral B DNA Detection
- Decision date
- 2020-05-14
- Decision code
- OK30
- Date received
- 2020-04-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional of a second supplier source for a manufacturing component.