|
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 | S019 |
Date Received | 03/01/2019 |
Decision Date | 04/22/2019 |
Product Code |
OYB |
Advisory Committee |
Microbiology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval to revise the release criteria for specificity testing of the Negative QC Panel Internal Control RLU parameter |