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GSP Neonatal Creatine Kinase -MM kit

Wallac Oy · Model 3311-001U · UDI-DI 06438147362615

QJE Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

For the quantitative determination of Creatine Kinase -MM (CK-MM) concentration in dried blood. Note: Kit contains multiple packages.

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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.