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510(k)

Abbott said that its Afinion HbA1c assay used to diagnose diabetes could eventually be made available in physicians' offices through a CLIA waiver.

Included in the 510(k) clearances was one for AMS Diagnostics' Liasys 600 Electrolyte Measurement System for measuring sodium, chloride, and potassium in human serum.

The test uses turbidimetry to measure levels of fecal calprotectin, a neutrophilic protein biomarker of intestinal mucosal inflammation.

The firm is also developing a methylated DNA biomarker test — called EsoCheck Dx — for Barrett's esophagus that uses samples collected with EsoCheck.

The test, cleared for use with Quidel’s Triage MeterPro instrument, uses monoclonal antibodies that are specific for the metabolites of nine drug classes.

Applied BioCode said that it now has access to higher volume laboratories that use the Roche MagNa Pure 96 System for sample extraction.

Siemens Healthineers received clearance for its Dimension Exl High-Sensitivity Troponin I Assay used to diagnose acute myocardial infarction.

Akonni has received clearance for a molecular diagnostic instrument and a saliva-based pharmacogenomics test for warfarin metabolism.

The self-administered test is designed to detect human chorionic gonadotropin levels in women as early as six days before a first missed period.

Clever Culture Systems said its platform can process more than 200 culture plates at a time and automatically screen, interpret, and sort them.

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