510(k)
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.
23andMe Gains FDA Clearance for Direct-to-Consumer Prostate Cancer Genetic Risk Test
The firm is now authorized to sell a genetic health report on the HOXB13 marker that indicates risk for hereditary prostate cancer, its third DTC cancer risk report with 510(k) clearance.
OpGen Receives FDA Clearance for AMR Panel, Prelim Q3 Revenues Up 9 Percent
The firm's Acuitas AMR Gene Panel tests for 28 genetic AMR markers in isolated bacterial colonies from 26 different pathogens.
NYU Langone Health Gets FDA Clearance for Solid Tumor Gene Sequencing Test
The test uses next-generation sequencing to detect cancer-linked mutations in 607 genes to help guide patient treatment.
FDA Clears Zymo Research Coronavirus Sample Collection Device
Zymo Research previously received CE-IVD marking for the collection device, which enables the transport and storage of SARS-CoV-2 RNA at ambient temperatures.
Sep 8, 2020
FDA Clears DiaSorin Test for Influenza, RSV
Sep 8, 2020
Roche BK Virus Test Garners FDA Clearance
Apr 30, 2020
FDA Provides Second Clearance for Binx MDx Platform
Jan 31, 2020
Dec 17, 2019
FDA Clears DiaSorin Molecular VZV Test
Nov 12, 2019
FDA Clears NantHealth Tumor-Normal Whole-Exome Test
Oct 1, 2019