PMA P000012S043

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S043
Product code: MZP
Decision date: 2013-06-24
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: CHANGE TO THE BULK TESTING REQUIREMENTS FOR POSITIVE CONTROL REAGENTS.

Current openFDA PMA Record

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST, V2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S043
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2013-06-24
Decision code: OK30
Date received: 2013-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO THE BULK TESTING REQUIREMENTS FOR POSITIVE CONTROL REAGENTS.