Jak2 Gene Mutation Detection Test
- US Product Code (FDA)
- PSUView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 866.6070View CFR Regulation →
- Medical specialty
- Medical Genetics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- No
- Third party review
- Not Eligible
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.
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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.
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