PMA P000012S044
- Device
- Cobas Amplicor Hcv Test, Cobas Ampliprep/cobas Amp
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S044
- Decision date
- 2013-09-12
Current openFDA PMA Record
- Device
- COBAS AMPLICOR HCV TEST, COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, VERSION 2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S044
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2013-09-12
- Decision code
- OK30
- Date received
- 2013-08-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE OLIGONUCLEOTIDE MANUFACTURING PROCESS FOR THE DEVICES.