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FDA clearance

Beckman Coulter got regulatory clearance for three in vitro diagnostic products, including its DxH 520 hematology analyzer for low-volume clinical labs.

The FDA cleared the firm's Coag-Sense PT2 second-generation PT/INR monitoring system for professional use in a CLIA setting and by patients at home.

The test detects Group A Strep in throat swab samples using the firm's rapid molecular diagnostics instrument called Revogene.

The Optigen AP 3600 can process up to 100 panels, or as many as 3,600 individual allergen results, in one day, and allows for true walk-away time, the firm said.

BioMérieux received clearance for its Vitek 2 gram-negative susceptibility card as a test used to determine the antimicrobial susceptibility of certain aerobic bacilli.

IL said that the rapid basic metabolic panel is designed for testing at the point of care, primarily in hospital emergency departments and clinical laboratories.

The agency said that the proposed exemption would apply only to cytometry instruments that are used for counting or characterizing cells.

The firm said that the panel is expected to receive CE marking for commercial availability in Europe later this year.

The firm said that its rapid flu detection platform helps reduce the subjectivity of interpreting test results and can be used in a broad range of healthcare settings.

The platform enables the assessment of hemoglobin levels at the point of care and quantitatively measures hemoglobin in capillary or venous whole blood.

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