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510(k)

Siemens Healthineers got the nod for its Advia Centaur CA 125 II Assay for detecting CA 125 to help in the management of patients with ovarian carcinoma.

The FDA cleared the point-of-care Binx io platform for the detection of chlamydia and gonorrhea in male urine specimens.

Abbott's RealTime CT/NG assay is currently only cleared by the US Food and Drug Administration for use with urogenital samples.

Under the clearance, capillary whole blood is no longer an acceptable sample type for the company's Blue i-Stat CG4+ cartridge.

BioMérieux's BioFire received clearance for its Blood Culture Identification 2 Panel for the identification of nucleic acids associated with bacteria and yeast.

If the proposal is finalized, the tests will go through a less burdensome process to obtain marketing clearances.

The Sectra Digital Pathology Module provides access to current and historical digital images of tissue samples, related data, and tools for image review.

The analyzer supports COVID-19 response efforts, where blood-gas testing plays a critical role in monitoring patients' respiratory distress, the firm said.

Abbott received five separate clearances associated with its i-Stat Chem8+ cartridge running on the company's iStat 1 system.

The assay will be available on the Vitros 3600 Immunodiagnostic System, Vitros 5600 and Vitros XT 7600 Integrated Systems, and Vitros ECi/ECiQ Systems. 

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