PMA P000012S042
- Device
- Cobas Amplicor Hcv Test V2.0,cobas Ampliprep/cobas
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S042
- Decision date
- 2013-06-07
Current openFDA PMA Record
- Device
- COBAS AMPLICOR HCV TEST V2.0,COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S042
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2013-06-07
- Decision code
- OK30
- Date received
- 2013-05-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO UPDATE THE SPECIFICATIONS FOR RECEIVING ACCEPTANCE OF A SUPPLIER¿S MATERIAL USED IN THE DEVICE.