PMA P110037S010
- Device
- AMPLIPREP/COBAS TAQMAN CMV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S010
- Product code
- PAB
- Decision date
- 2013-10-09
- Classification
- Cytomegalovirus (cmv) Dna Quantitative Assay
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Approval order statement
- CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- AMPLIPREP/COBAS TAQMAN CMV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P110037
- Supplement
- S010
- Product code
- PAB
- Generic name
- Cytomegalovirus (cmv) dna quantitative assay
- Decision date
- 2013-10-09
- Decision code
- OK30
- Date received
- 2013-09-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FOR THE ADDITION OF A NEW SUPPLIER OF SUB-ASSEMBLIES USED IN THE PRODUCTION OF THE INSTRUMENT FOR THE DEVICES.