Title of article - In Reply.
Abstract
The Food and Drug Administration (FDA) has classified an autosomal recessive carrier screening gene mutation detection system into class II (special controls). The special controls that apply to this device are identified in this order and will be part of the codified language for the autosomal recessive carrier screening gene mutation detection system classification. The Agency has classified the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
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Details of Journal for In Reply.
Journal Title - Obstetrics and gynecology
ISSN - 1873-233X
Volume - 126
Issue - 3
Publish date - 2015-Sep
Language - eng
Country - United States
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