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.
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.
Jan 31, 2020
NeuMoDx T. Vaginalis, M. Genitalium Assay CE Marked
May 29, 2019
FDA Clears Two Hologic Vaginitis Assays
Mar 6, 2018