|
Device | Aptima HPV 16 18/45 Genotype 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 | S025 |
Date Received | 11/01/2019 |
Decision Date | 04/27/2020 |
Product Code |
OYB |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the use of ThinPrep 5000 post-processed samples on the Aptima HPV 16 18/45 Genotype assay. |