|
Device | COBAS AMPLIPREP/COBAS TAQMAN CMV 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 | S002 |
Date Received | 08/15/2012 |
Decision Date | 09/14/2012 |
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 CHANGE TO ADJUST THE ENVIRONMENTAL TESTING PERFORMED AT THE RMS BRANCHBURG FACILITY. |