|
Device | BD Onclarity HPV Assay, BD Viper LT System |
Generic Name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
Applicant | BECTON, DICKINSON AND COMPANY 7 LOVETON CIRCLE SPARKS, MD 21152 |
PMA Number | P160037 |
Supplement Number | S001 |
Date Received | 04/27/2018 |
Decision Date | 03/26/2019 |
Product Code |
MAQ |
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 a change to plastic resin used for reagent storage containers. |