Visby Medical Point-of-Care STI Test Gets FDA 510(k) Clearance, CLIA Waiver
The PCR test detects sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis in women.
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.
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
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