The FDA cleared BD's test for detecting carbapenemase-producing organisms, which can be used by hospitals to contain the spread of antimicrobial resistance.
The FDA cleared LabCorp's assay for quantitative determination of total cholesterol, high density lipoprotein cholesterol, triglycerides, and apolipoprotein B.
Used with other clinical evidence, Siemen Healthineer's blood-based test aids clinicians in assessing the fibrosis stage of chronic liver disease.
The miniature analyzer, which uses disposable cartridges that include all necessary reagents, is designed to provide results from one drop of blood.
The Vitros HIV Combo test is a fourth-generation test that detects HIV-1 and HV-2 antibodies, and the p24 antigen, resulting in earlier detections of the disease.
The cleared system enables testing on a postage stamp-size piece of film along with advanced optics for precise results, Ortho said.
The fully automated system has 12 independent thermal cyclers and runs the firm's diagnostic kits, but it can also operate as an open instrument.
Abbott said that the next-generation molecular POC assays have also been CLIA waived for use on the Abbott ID NOW instrument, formerly called Alere i.
The device is designed to be used with the Inova Diagnostics' Quanta Flash assay for the detection of fecal calprotectin in human stool samples.
The agency granted clearance for the Ansh Labs PicoAMH ELISA test, which measures the amount of Anti-Müllerian hormone in the blood.