ARTICLE
15 September 2014

FDA Classifies EGR1 Gene Fish Test As Class II Device

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In the September 3, 2014, Federal Register, FDA issued a final order classifying early growth response 1 ("EGR1") gene fluorescence in-situ hybridization ("FISH") test system for specimen characterization into class II (special controls).
United States Food, Drugs, Healthcare, Life Sciences

In the September 3, 2014, Federal Register, FDA issued a final order classifying early growth response 1 ("EGR1") gene fluorescence in-situ hybridization ("FISH") test system for specimen characterization into class II (special controls). Effective October 3, 2014.

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