To maintain the quality of laboratory testing, CLIA requires that laboratories performing moderate or high-complexity testing enroll in an approved proficiency testing program for independent ...

New regulations under the Clinical Laboratory Improvement Amendments (CLIA) introduced updated proficiency testing (PT) and PT referral rules that are now in effect. Although the regulations became ...

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 ...

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PALO ALTO, Calif.--(BUSINESS WIRE)--Theranos, Inc. (Theranos) today announced that its test and Theranos test system for the herpes simplex 1 virus IgG (HSV-1), which was cleared by the U.S. Food and ...

BOSTON--(BUSINESS WIRE)--binx health, a healthcare technology and women’s health company focused on making routine testing broadly accessible and convenient, announced today the launch of its ...

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 ...

The CLIA-waived CitoCBC® expands patient access to quick CBC results in physician offices, pharmacies, and home care, enabling data-driven diagnostics. CBC is one of the most commonly requested lab ...

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 ...

But you have to have a CLIA-waived certificate in order to do CLIA-waived tests.” Gutteling said there are also some types testing for COVID, flu, respiratory syncytial virus (RSV) and some sexually ...