Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S003 |
Date Received | 06/09/2014 |
Decision Date | 07/07/2014 |
Product Code |
OYB |
Advisory Committee |
Microbiology |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE TO REVISE AN INTERNAL CONTROL QC RELEASE TEST SPECIFICATION FOR THE APTIMA® HPV ASSAY. |
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