PMA P110037S009
- Device
- COBAS AMPLIPREP/COBAS TAQMAN CMV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S009
- Product code
- PAB
- Decision date
- 2013-09-12
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- COBAS AMPLIPREP/COBAS TAQMAN CMV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S009
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2013-09-12
- Decision code
- OK30
- Date received
- 2013-08-14
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.