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Jak2 Gene Mutation Detection Test

Jak2 Gene Mutation Detection Test is a medical device type in the Medical Genetics specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

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Jak2 Gene Mutation Detection Test
Medical Genetics Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

PSU

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Class 2

21 CFR 866.6070

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Medical Genetics

Device Characteristics

No

No

No

Not Eligible

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.