PMA P000012S029

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S029
Product code: MZP
Decision date: 2011-03-22
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: DISCONTINUATION OF FINAL BULK TESTING REQUIREMENTS FOR BULK QUANTITATION STANDARD (QS) AND INTERNAL CONTROL (IC) REAGENTS FOR 17 QS/IC PRODUCTS USED WITH THE ASSOCIATED ASSAYS.

Current openFDA PMA Record

Device: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST V2.0
Applicant: Roche Molecular Systems, Inc.
PMA number: P000012
Supplement: S029
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2011-03-22
Decision code: OK30
Date received: 2011-03-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: DISCONTINUATION OF FINAL BULK TESTING REQUIREMENTS FOR BULK QUANTITATION STANDARD (QS) AND INTERNAL CONTROL (IC) REAGENTS FOR 17 QS/IC PRODUCTS USED WITH THE ASSOCIATED ASSAYS.