PMA P000012S038
- Device
- Cobas Ampliprep / Cobas Amplicor Hcv V2.0 And Coba
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S038
- Decision date
- 2012-06-07
Current openFDA PMA Record
- Device
- COBAS AMPLIPREP / COBAS AMPLICOR HCV V2.0 AND COBAS AMPLICOR HCV TEST, V2.0
- Applicant
- Roche Molecular Systems, Inc.
- PMA number
- P000012
- Supplement
- S038
- Product code
- MZP
- Generic name
- Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
- Decision date
- 2012-06-07
- Decision code
- APPR
- Date received
- 2012-03-29
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC., IN SOMERVILLE, NEW JERSEY.