|
Device | COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST |
Generic Name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
Regulation Number | 866.3170 |
Applicant | Roche Molecular Systems, Inc. 4300 HACIENDA DR. PLEASANTON, CA 94588-0900 |
PMA Number | P000012 |
Supplement Number | S028 |
Date Received | 09/24/2010 |
Decision Date | 12/10/2010 |
Withdrawal Date
|
08/26/2016 |
Product Code |
MZP |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO REPLACE THE AMPLICON INACTIVATION TEST THAT IS CURRENTLY PERFORMED ON HCV MASTER MIXES (MMX) DURING IN-PROCESS RELEASE TESTING WITH A RECOMBINANT ENZYME URACIL-N-GLYCOSYLASE (RUNG) ACTIVITY TEST. |