|
Device | COBAS AMPLIPREP/COBAS TAQMAN 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 Drive Pleasanton, CA 94588-2722 |
PMA Number | P060030 |
Supplement Number | S009 |
Date Received | 03/01/2010 |
Decision Date | 03/24/2010 |
Reclassified Date
|
12/22/2021 |
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 CLEAN IN PLACE (CIP) CYCLE CHANGES AND MINOR EQUIPMENT MODIFICATIONS FOR THE SCALE BULK FORMULATION TANKS AND THEIR ASSOCIATED FILLING TRANSFER LINES. |