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e-CFR data is current as of July 14, 2020

Title 21Chapter ISubchapter HPart 866Subpart D → §866.3860


Title 21: Food and Drugs
PART 866—IMMUNOLOGY AND MICROBIOLOGY DEVICES
Subpart D—Serological Reagents


§866.3860   Trichomonas vaginalis nucleic acid assay.

(a) Identification. A Trichomonas vaginalis nucleic acid assay is a device that consists of primers, probes, enzymes, and controls for the amplification and detection of trichomonas nucleic acids in endocervical swabs, vaginal swabs, and female urine specimens, from women symptomatic for vaginitis, cervicitis, or urethritis and/or to aid in the diagnosis of trichomoniasis in asymptomatic women. The detection of trichomonas nucleic acids, in conjunction with other laboratory tests, aids in the clinical laboratory diagnosis of trichomoniasis caused by Trichomonas vaginalis.

(b) Classification. Class II (special controls). The special controls are set forth in FDA's guideline document entitled: “Class II Special Controls Guideline: Nucleic Acid Amplification Assays for the Detection of Trichomonas vaginalis; Guideline for Industry and Food and Drug Administration Staff.” See §866.1(e) for information on obtaining this document.

[80 FR 46192, Aug. 4, 2015]

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