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BioHermes Glycohemoglobin Test Kit

Wuxi Biohermes Bio & Medical Technology Co.,Ltd. · Model A1C-EXP S01 · UDI-DI 06935784411176

510(k) clearances

Adverse events

Recalls

Facilities

Description

A1cChek Express Glycohemoglobin Test Kit ( Boronate Affinity Chromatography), 25 Tests/Kit . Intended use: This A1cChek Express glycohemoglobin test kit is intended to be used with the A1cChek Express glycohemoglobin analyzer to quantitatively measure glycohemoglobin (HbA1c)level in whole blood (capillary blood or venous blood). Contents: HbA1c Test Strip x 25; Sampler x 25; Buffer Kit x 1; Rinse Card x 1; Code Chip x 1; lnsert x 1.

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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.