PMA P000012S053

Device: COBAS AMPLICOR HCV TEST , VERSION 2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S053
Product code: MZP
Decision date: 2015-04-09
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.

Current openFDA PMA Record

Device: COBAS AMPLICOR HCV TEST , VERSION 2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S053
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2015-04-09
Decision code: OK30
Date received: 2015-03-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE CURRENT SUPPLIER, AND A CHANGE TO THE MANUFACTURING PROCESS FORA REAGENT MATERIAL USED FOR THE COBAS® SYSTEMS.