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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 (ODxT Test)
Generic Namenext generation sequencing oncology panel, somatic or germline variant detection system
Applicant
LIFE TECHNOLOGIES CORPORATION
5781 van allen way
carlsbad, CA 92008
PMA NumberP160045
Supplement NumberS029
Date Received05/03/2021
Decision Date09/15/2021
Product Code PQP 
Docket Number 21M-1023
Notice Date 11/08/2021
Advisory Committee Pathology
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to expand the intended use of the Oncomine Dx Target Test to include a companion diagnostic indication for the detection of EGFR exon 20 insertion mutations in non-small cell lung cancer patients who may benefit from the treatment with EXKIVITY (mobocertinib).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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