|
Device | APTIMA HPV ASSAY |
Generic Name | Kit, rna detection, human papillomavirus |
Applicant | GEN-PROBE INCORPORATED 10210 Genetic Center Drive San Diego, CA 92121 |
PMA Number | P100042 |
Supplement Number | S008 |
Date Received | 08/28/2015 |
Decision Date | 09/19/2016 |
Product Code |
OYB |
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 of a new supplier for a critical raw material. |