PMA P110037S060
- Device
- COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S060
- Product code
- PAB
- Decision date
- 2023-12-14
- Classification
- Microbiology
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- to eliminate an in-process test determined to be unnecessary
Current openFDA PMA Record#
- Device
- COBAS® AmpliPrep® / COBAS® TaqMan® CMV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S060
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2023-12-14
- Decision code
- OK30
- Date received
- 2023-12-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to eliminate an in-process test determined to be unnecessary