PMA P000010S015

Device: AMPLICOR HCV TEST, VERSION 2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000010
Supplement: S015
Product code: MZP
Decision date: 2010-04-08
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: ROOM CHANGES FOR THE MANUFACTURE OF QUANTITATION STANDARD AND INTERNAL CONTROL REAGENTS.

Current openFDA PMA Record

Device: AMPLICOR HCV TEST, VERSION 2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000010
Supplement: S015
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2010-04-08
Decision code: OK30
Date received: 2009-12-24
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ROOM CHANGES FOR THE MANUFACTURE OF QUANTITATION STANDARD AND INTERNAL CONTROL REAGENTS.