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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceOncomine Dx Target Test
Generic NameNext generation sequencing oncology panel, somatic or germline variant detection system
ApplicantLIFE TECHNOLOGIES CORPORATION
5781 VAN ALLEN WAY
CARLSBAD, CA 92008
PMA NumberP160045
Supplement NumberS034
Date Received12/23/2021
Decision Date01/21/2022
Product Code PQP 
Advisory Committee Pathology
Clinical TrialsNCT02609776
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval of the clinical protocol titled Oncomine Dx Target Test Clinical Validation Protocol: Biomarker EGFR Exon 20 Insertions (Olympic) - PRJ0002127 Supplemental Sample Study, for the post-approval study (PAS) protocol.
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