|
Device | COBAS AMPLIPREP/COBAS TAQ/MAN 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 | S016 |
Date Received | 12/16/2014 |
Decision Date | 03/26/2015 |
Product Code |
PAB |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR SOFTWARE CHANGES TO THE TOTAL ASPIRATION AND DISPENSEMONITORING (TADM) TOLERANCE BAND PARAMETERS FOR THE COBAS P 630 INSTRUMENT FOR PIPETTING CAP/CTM CMV CONTROLS. |