PMA P000010S016

Device: AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000010
Supplement: S016
Product code: MZP
Decision date: 2010-04-07
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: CHANGES TO THE CIP PROCESS FOR THE BULK FORMULATION TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINES, AND MINOR MODIFICATIONS TO THE HOPPER EQUIPMENT USED IN THE FORMULATION OF BULK REAGENTS FOR THE DEVICE.

Current openFDA PMA Record

Device: AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000010
Supplement: S016
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2010-04-07
Decision code: OK30
Date received: 2010-03-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO THE CIP PROCESS FOR THE BULK FORMULATION TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINES, AND MINOR MODIFICATIONS TO THE HOPPER EQUIPMENT USED IN THE FORMULATION OF BULK REAGENTS FOR THE DEVICE.