CLIA
Telo Genomics Gets CLIA Certification for Clinical Laboratory
The certification enables the Canadian cancer testing firm to offer clinical lab services in the US and to distribute its TeloView prognostic products in the US and elsewhere.
Nuclein Submits Combo COVID, Flu Point-of-Care RT-qPCR Test for FDA 510(k) Clearance, CLIA Waiver
The cartridge-based test detects SARS-CoV-2, influenza A, and influenza B in approximately 15 minutes.
BioMérieux Respiratory/Sore Throat Mini Panel Gets FDA Special 510(k) Clearance, CLIA Waiver
The firm said that it expects its SpotFire Respiratory/Sore Throat (R/ST) Panel Mini test to be available in the US in the third quarter of 2024.
BioMérieux Gets FDA 510(k) Clearance, CLIA Waiver for Respiratory, Throat Infection PCR Test
The panel runs on BioMérieux's SpotFire system for rapid point-of-care molecular diagnostic testing.
AMP Petitions Congress to Revisit CLIA Update, Eyes Legal Action Against New Proposed FDA LDT Rule
While AMP asked members to register their opposition officially, one official said "there probably will be a lawsuit."
Jun 29, 2023
May 8, 2023
Devyser Gets CLIA Certification for Atlanta Lab
Oct 11, 2022
Jun 6, 2022
Bluestar Genomics Gets CLIA Certification
Apr 27, 2022
Neogen Obtains CLIA Certification for Genomics Lab
Mar 30, 2021
Binx Health Chlamydia and Gonorrhea Test CLIA Waived
Dec 10, 2020