Nasdaq

Chembio Announces the Receipt of CLIA Waiver for its DPP HIV-Syphilis System

MEDFORD, N.Y., Feb. 24, 2023 (GLOBE NEWSWIRE) -- Chembio Diagnostics, Inc. (Nasdaq: CEMI), a leading point-of-care diagnostics company focused on infectious diseases, today announced receipt of a ...
Business Insider

binx health Receives FDA CLIA Waiver for Chlamydia and Gonorrhea Test, Expanding Critical Access to Single-Visit Diagnoses

BOSTON, March 30, 2021 /PRNewswire/ -- binx health, a population health technology company that provides convenient healthcare solutions, announced today that the US Food and Drug Administration (FDA) ...
Seeking Alpha

Cepheid Receives FDA Authorization with CLIA Waiver for Xpert® HCV

Detection of hepatitis C virus (HCV) in about an hour SUNNYVALE, Calif., June 27, 2024 /PRNewswire/ -- Cepheid announced today that it has received FDA De Novo marketing authorization and Clinical ...
Becker's Hospital Review

FDA approves 1st COVID-19 test cleared with CLIA waiver

The FDA cleared for commercial distribution a diagnostic panel that tests for multiple respiratory viral and bacterial infections on Feb. 3. The BioFire Spotfire Respiratory Panel is the first ...
Seeking Alpha

Nuclein Receives Dual FDA 510(k) Clearance and CLIA Waiver for DASH® SARS-CoV-2 & Flu A/B Test for use on the DASH® Rapid PCR System

AUSTIN, Texas, Jan. 6, 2025 /PRNewswire/ -- Nuclein, a leader in rapid, point-of-care molecular diagnostics, today announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance ...
Nasdaq

QuidelOrtho's (QDEL) Rapid Antigen Test Gets CLIA Waiver

QuidelOrtho Corporation QDEL recently announced that it has been granted a CLIA Waiver by the FDA, which applies to its new Sofia 2 SARS Antigen+ FIA (fluorescent immunoassay). The Sofia 2 SARS ...
News Medical

FDA waiver broadens the use of chlamydia and gonorrhea test at more point-of-care settings

Today, the U.S. Food and Drug Administration announced it is allowing the use of the Binx Health IO CT/NG Assay at point-of-care settings, such as in physician offices, community-based clinics, urgent ...