PMA P000010S017

Device: AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000010
Supplement: S017
Product code: MZP
Decision date: 2010-09-23
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: CHANGES TO REDUCE THE BATCH SIZE FOR MANUFACTURE OF SUBSTRATE A, SUBATRATE B, STOP REAGENT AND WASH CONCENTRATE BULK SOLUTION.

Current openFDA PMA Record

Device: AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000010
Supplement: S017
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2010-09-23
Decision code: OK30
Date received: 2010-08-27
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGES TO REDUCE THE BATCH SIZE FOR MANUFACTURE OF SUBSTRATE A, SUBATRATE B, STOP REAGENT AND WASH CONCENTRATE BULK SOLUTION.