Trichomonas vaginalis
The firm received clearance and CLIA waiver for a 30-minute point-of-care PCR assay for three common STIs earlier this week.
Visby Medical Obtains FDA 510(k), CLIA Waiver for Multiplex STI Test Using Handheld PCR Device
The CLIA waiver enables clinicians to run a 30-minute multiplex test for chlamydia, gonorrhea, and trichomonas during a patient's visit.
New York State Approves Enzo Biochem STI Tests on GenFlex Platform
The GenFlex is a sample-to-result molecular diagnostic platform that includes sample collection, processing, amplification, and detection, the company said.
NeuMoDx T. Vaginalis, M. Genitalium Assay CE Marked
The molecular assay detects and differentiates Trichomonas vaginalis and/or Mycoplasma genitalium in clinical urine samples.
Rheonix Submits MDx System, Triplex Sexually Transmitted Infections Test to FDA
The Ithaca, New York-based firm has submitted its molecular diagnostic instrument along with a test to detect chlamydia, gonorrhea, and trichomonas.
May 29, 2019
FDA Clears Two Hologic Vaginitis Assays
Mar 6, 2018
Qiagen Trichomonas Assay Gets CE Mark
Sep 3, 2014
Cepheid Trichomoniasis Test Gets CE-IVD Mark
Jan 14, 2013
Hologic Gets FDA Clearance for Trichomonas Assay
Feb 16, 2012
Apr 20, 2011
FDA Clears Gen-Probe's Trichomonas Assay
Oct 5, 2010