Medical Devices; Immunology and Microbiology Devices; Classification of Trichomonas Vaginalis Nucleic Acid Assay
fda-device · Food and Drug Administration · Rule · Published 2015-08-04 · Effective 2015-08-04 · 80 FR 46190
Document
Document number
2015-19072
Federal Register citation
80 FR 46190
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2015-08-04
Effective date
2015-08-04
HHS docket
Docket No. FDA-2015-N-2526
Abstract
The Food and Drug Administration (FDA) is classifying a Trichomonas vaginalis nucleic acid 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.