|
Device | COBAS AmpliPrep/COBAS TaqMan Cytomegalovirus Test |
Generic Name | Cytomegalovirus (cmv) dna quantitative assay |
Applicant | Roche Molecular Systems, Inc. 4300 Hacienda Drive Pleasanton, CA 94588-2722 |
PMA Number | P110037 |
Supplement Number | S029 |
Date Received | 09/22/2016 |
Decision Date | 10/18/2016 |
Product Code |
PAB |
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 Implementation of AQL sampling in place of online 100% visual inspection for vials filled on 3 high-speed filling lines. |