|
Device | Abbott Real Time CMV Amplification Reagent Kit / CMV Control Kit / CMV Calibrator Kit. |
Generic Name | Cytomegalovirus (cmv) dna quantitative assay |
Applicant | ABBOTT MOLECULAR 1300 EAST TOUHY AVENUE DES PLAINES, IL 60018 |
PMA Number | P160044 |
Supplement Number | S001 |
Date Received | 06/27/2017 |
Decision Date | 09/01/2017 |
Product Code |
PAB |
Advisory Committee |
Microbiology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for changes to the polypropylene resin, cap colorant and inside diameter of the tubes and screw-caps used for storage and transport of the finished calibrators and controls, and for the master mix assembly. |