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FDA clearance

The FDA cleared a CellaVision test that provides differential counts of white blood cells, characterization of red blood cell morphology, and platelet estimations.

Fujirebio Diagnostics got the nod for a chemiluminescent enzyme immunoassay to measure levels of CA 15-3 and manage patients diagnosed with breast cancer.

The single-use, multiplex immunoassay provides results in 15 minutes and detects antibodies to HIV types 1 and 2 as well as Treponema pallidum.

The single-visit blood test is one of two FDA-cleared alternatives to the traditional tuberculin skin test, according to Oxford Immunotec.

The additions improve the system's performance and expand its antimicrobial susceptibility testing menu for bloodstream infections.

 

The FDA granted clearance to consumer genetic testing company Ancestry.com for the over-the-counter use of a health risk test for hereditary thrombophilia.

The test is for use with the company's Liaison MDx instrument and can be used alone or with the Simplexa COVID-19 Direct kit.

The RT-PCR test runs on the Cobas 6800/8800 Systems and had previously received breakthrough device designation from the FDA.

Streck said its collection tube maintains native cell-free DNA populations and provides sample integrity by reducing the release of cellular genomic DNA.

The sequencing-based test for minimal residual disease can be use with blood and bone marrow samples in patients with chronic lymphocytic leukemia.

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