PMA P000012S031

Device: COBAS AMPLICOR HCV TEST, V2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S031
Product code: MZP
Decision date: 2011-12-29
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: APPROVAL FOR A MANUFACTURING SITE LOCATED AT ROCHE MOLECULAR SYSTEMS, INC. IN SOMERVILLE, NEW JERSEY.

Current openFDA PMA Record

Device: COBAS AMPLICOR HCV TEST, V2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S031
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2011-12-29
Decision code: APPR
Date received: 2011-05-31
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.