PMA P000012S022
- Device
- Cobas Amplicor Hcv Test And Cobas Ampliprep/cobas
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S022
- Decision date
- 2010-04-08
Current openFDA PMA Record
- Device
- COBAS AMPLICOR HCV TEST AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S022
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2010-04-08
- Decision code
- OK30
- Date received
- 2009-12-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ROOM CHANGES FOR THE MANUFACTURE OF QUANTITATION STANDARD AND INTERNAL CONTROL REAGENTS.