Chlamydia trachomatis
Becton Dickinson High-Throughput MDx Module, Triplex STI Test Get FDA 510(k)Clearance
Along with a sample prep module, the BD Cor MX module is capable of delivering as many as 1,000 sample results in 24 hours.
BD Gets CE Mark, Australian Regulatory Approval for New Cor MX Instrument
The new MX instrument, which is based on the firm's BD Max PCR instrument, is the final component of the high-throughput BD Cor system.
As the pandemic continues to play out, test developers aren't sure how it will impact STIs and their work around developing and manufacturing tests.
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.
Mar 30, 2021
Binx Health Chlamydia and Gonorrhea Test CLIA Waived
Aug 15, 2018
Apr 16, 2018
FDA Clears Roche CT/NG Assay for 6800, 8800 Systems
Jan 23, 2017
Atlas Genetics Raises $35M in Series D Fundraising
Dec 5, 2013