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Medical Devices / Submissions and Approvals

FDA Grants Clearance for Ortho Clinical’s Chemistry Product Slides

April 11, 2019
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The FDA granted 510(k) clearance for Ortho Clinical Diagnostics’ Vitros XT microslides, a product that couples various tests that physicians usually order together.

The test pairs, which can run simultaneously using the Vitros XT 7600 integrated system, include urea and creatinine, glucose and calcium, and triglycerides and cholesterol.

The microslides enable a higher test throughput without the need for additional or larger analyzers and require smaller blood samples, which is helpful for vulnerable patients and patients with venous access issues.

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