PMA P000010S019

Device: AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000010
Supplement: S019
Product code: MZP
Decision date: 2011-08-17
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Approval order statement: APPROVAL FOR CHANGES MADE TO THE ACCEPTANCE CRITERIA FOR A CONJUGATE BULK SOLUTION USED IN THE DEVICE.

Current openFDA PMA Record

Device: AMPLICOR HCV TEST
Applicant: Roche Molecular Systems, Inc.
PMA number: P000010
Supplement: S019
Product code: MZP
Generic name: Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Decision date: 2011-08-17
Decision code: APPR
Date received: 2011-02-08
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR CHANGES MADE TO THE ACCEPTANCE CRITERIA FOR A CONJUGATE BULK SOLUTION USED IN THE DEVICE.