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 | Praxis Extended RAS Panel |
Generic Name | Next generation sequencing oncology panel, somatic or germline variant detection system |
Applicant | Illumina, Inc. 5200 ILLUMINA WAY SAN DIEGO, CA 92122 |
PMA Number | P160038 |
Supplement Number | S019 |
Date Received | 12/30/2020 |
Decision Date | 07/29/2021 |
Withdrawal Date
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12/22/2023 |
Product Code |
PQP |
Advisory Committee |
Pathology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at Illumina Singapore, 29 Woodlands Industrial Park E1, Singapore, South East 757716, for manufacturing of MiSeqDx Cartridge and MiSeqDx Flow Cell. |
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