Medical Devices; Immunology and Microbiology Devices; Classification of Gastrointestinal Microorganism Multiplex Nucleic Acid-Based Assay
fda-device · Food and Drug Administration · Rule · Published 2015-11-02 · Effective 2015-11-02 · 80 FR 67313
Document
Document number
2015-27817
Federal Register citation
80 FR 67313
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-11-02
Effective date
2015-11-02
HHS docket
Docket No. FDA-2015-N-3392
Abstract
The Food and Drug Administration (FDA) is classifying a gastrointestinal microorganism multiplex nucleic acid-based assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.