The laboratories at the Hilo Urgent Care and Keaau Urgent Care clinics are now in full state and federal compliance and are legally able to conduct the same type of lab testing they’ve done for 22 ...

HighER Level Urgent Care offers CBC testing enabled by CitoCBC®, a CLIA-waived blood analyzer designed for use in ...

Neural-Network Based Cell Analysis This clearance follows four years of regulatory engagement with the FDA to validate AI-native diagnostics in clinical environments. Athelas Home uses ...

The US Food and Drug Administration (FDA) has cleared a complete blood cell count (CBC) test that can be run in more healthcare settings, including physicians' offices, clinics, or other types of ...

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) ...

Diagnostics Direct, LLC., a leading provider of in-office diagnostic tests, is pleased to announce the launch of the first CLIA-Waived rapid treponemal syphilis test: Syphilis Health Check™. The U.S.

Cepheid 's CPHD rapid influenza and RSV assay - the Xpert Flu+RSV Xpress test - recently won the U.S. FDA 510(k) marketing approval and the Clinical Laboratory Improvement Achievements (CLIA) waiver.

The membership-based medical practice offers CBC testing enabled by CitoCBC®, a CLIAwaived blood analyzer designed for ...

Gutteling said the federal and state permits allow his labs to conduct what he called “CLIA-waived testing.” According to the federal Centers for Medicare and Medicaid Services, CLIA certification ...