|
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 | S008 |
Date Received | 03/01/2016 |
Decision Date | 03/28/2016 |
Product Code |
OYB |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Scale up of the manufacturing process for three solutions used in the Aptima HPV 16 18/45 Genotype assay. |