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Siemens lands FDA clearance for BUN, TC02 tests

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Feb. 1, 2018Siemens Healthineers announced today it received 510(k) clearance from the FDA for its blood urea nitrogen (BUN) and total carbon dioxide (TCO2) point-of-care tests to aid in the diagnosis of renal diseases and metabolic imbalances. Siemens can now provide a full menu on a single test card within the blood analysis market for clinicians to perform at the patient bedside on the handheld Epoc Blood Analysis System.

“With the Epoc system, these new assays will expand the patient information clinicians can access sooner to help rule in or rule out potential diagnoses more quickly,” Michael Sampson, the company’s senior vice president of Point of Care Diagnostics, North America, said in a statement. “Rapid, informed diagnoses and treatment decisions at the patient side ultimately aids in improving clinical outcomes.”

The Epoc Blood Analysis System delivers results for pH, partial pressure of oxygen, partial pressure of carbon dioxide, sodium, potassium, ionized calcium, hematocrit, glucose, lactate, creatinine, chloride, and soon BUN and TCO2, in less than a minute. Results are integrated into any laboratory information system.

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