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Hemosure® Accu-Reader®

W.H.P.M. INC. · Model A100 · UDI-DI 00817763022770

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Description

Hemosure® Accu-Reader® A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader® A100 is comprised of Hemosure® Accu-Reader® A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader® A100 Control and Hemosure® Accu-Reader® A100 Calibration Cartridge Kit.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.