PMA P000012S052

Device: COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S052
Product code: MZP
Decision date: 2015-01-15
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: CHANGE TO THE HPLC SYSTEM QUALIFICATION RETENTION TIME WINDOW FOR THE PURIFICATION OF AN OLIGONUCLEOTIDE.

Current openFDA PMA Record

Device: COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST, VERSION 2.0 AND COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST VERSION 2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S052
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2015-01-15
Decision code: OK30
Date received: 2014-12-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE HPLC SYSTEM QUALIFICATION RETENTION TIME WINDOW FOR THE PURIFICATION OF AN OLIGONUCLEOTIDE.