PMA P110037S033
- Device
- Cobas AmpliPrep/Cobas TaqMan CMV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S033
- Product code
- PAB
- Decision date
- 2017-12-20
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- Remove a Quality Control test performed on finished analyzers.
Current openFDA PMA Record#
- Device
- Cobas AmpliPrep/Cobas TaqMan CMV Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S033
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2017-12-20
- Decision code
- OK30
- Date received
- 2017-11-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove a Quality Control test performed on finished analyzers.