PMA P050028S007
- Device
- COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S007
- Decision date
- 2010-02-04
- Approval order statement
- ELIMINATION OF IN-PROCESS CHEMICAL TESTING OF A BUFFER CONCENTRATE USED TO PREPARE THE MASTER MIX COMPONENT OF THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM.
Current openFDA PMA Record#
- Device
- COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P050028
- Supplement
- S007
- Decision date
- 2010-02-04
- Decision code
- OK30
- Date received
- 2010-01-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATION OF IN-PROCESS CHEMICAL TESTING OF A BUFFER CONCENTRATE USED TO PREPARE THE MASTER MIX COMPONENT OF THE COBAS TAQMAN HBV TEST FOR USE WITH THE HIGH PURE SYSTEM.