PMA P110037S027
- Device
- COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S027
- Product code
- PAB
- Decision date
- 2016-08-04
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Addition of a new fermenter used in the manufacturing process for enzymes.
Current openFDA PMA Record#
- Device
- COBAS® AMPLIPREP/COBAS® TAQMAN® CMV TEST (CAP/CTM CMV TEST)
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S027
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2016-08-04
- Decision code
- OK30
- Date received
- 2016-07-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new fermenter used in the manufacturing process for enzymes.