510(k)
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.
Luminex Nabs $11.3M From BARDA to Develop Test for SARS-CoV-2, Flu, RSV
The firm said it intends to apply to obtain FDA Emergency Use Authorization and 510(k) clearance for a panel that detects respiratory targets in a single test.
Roche Receives FDA Clearance for Cobas BKV Test for Use With Urine Samples
The test was previously cleared by the FDA for use with ethylenediaminetetraacetic acid plasma samples to manage BK virus in transplant patients.
Mesa Biotech Receives 510(k) Clearance, CLIA Waiver for Strep A Molecular Point-of-Care Test
The firm said its test fits in the palm of a hand and delivers results in 30 minutes by detecting bacterial nucleic acid in throat, nasal, or nasopharyngeal swabs.
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
FDA Clears Luminex Aries MRSA Assay
Apr 30, 2019