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 | Oncomine Dx Target Test |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | LIFE TECHNOLOGIES CORPORATION 5781 VAN ALLEN WAY CARLSBAD, CA 92008 |
PMA Number | P160045 |
Supplement Number | S021 |
Date Received | 07/27/2020 |
Decision Date | 10/23/2020 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the expansion of shelf-life claim of the Oncomine Dx Target Test (ODxT Test) from 9 to 23 months. |
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