United States:
FDA Classifies EGR1 Gene Fish Test As Class II Device
15 September 2014
Jones Day
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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). Effective October 3,
2014.
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