PMA P000012S046
- Device
- Cobas Ampliprep/cobas Amplicor Hcv Test
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S046
- Decision date
- 2013-10-09
Current openFDA PMA Record
- Device
- COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S046
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- 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.