|
Device | APTIMA HPV 16 18/45 GENETYPE ASSAY |
Generic Name | Kit, rna detection, human papillomavirus |
Applicant | GEN-PROBE INCORPORATED 10210 Genetic Center Drive San Diego, CA 92121 |
PMA Number | P120007 |
Supplement Number | S002 |
Date Received | 04/17/2014 |
Decision Date | 04/29/2014 |
Product Code |
OYB |
Advisory Committee |
Microbiology |
Clinical Trials | NCT01384370
|
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MINOR SOFTWARE CHANGES FOR THE APTIMA HPV ASSAY SOFTWARE (V2.3.5), THE APTIMA HPV-GT ASSAY SOFTWARE (V2.7.5), PANTHER SYSTEM SOFTWARE (V5.2). |
Post-Approval Study | Show Report Schedule and Study Progress |