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Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Kit

AXIS-SHIELD DIAGNOSTICS LIMITED · Model FHRWR1000 · UDI-DI 05055845400183

Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

The Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.