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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device jak2 gene mutation detection test
Definition The JAK2 gene mutation detection system is a device used to detect mutations and variants in the JAK2 gene. It is intended for use as an adjunct to evaluation of suspected Polycythemia Vera, in conjunction with other clinicopathological factors.
Product CodePSU
Regulation Number 866.6070
Device Class 2

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