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Procleix Syscheck

GRIFOLS DIAGNOSTIC SOLUTIONS INC. · Model Instrument Verification Solution · UDI-DI 00859882007405

Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

A collection of reagents and other associated materials intended to be used to generate a chemiluminescent signal when performing an assay using a nucleic acid technique (NAT) on a clinical specimen. It may also include reference material to optimize and verify performance of the luminometer instrument.

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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.