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PakAuto®

IMMUCOR GTI DIAGNOSTICS, INC. · Model PAKAUTO-MAYO · UDI-DI 10888234500728

MYP
0
510(k) clearances
7
Adverse events (1 deaths)
0
Recalls
2
Facilities

Description

PakAuto assay is a qualitative solid phase enzyme linked immunosorbent assay (ELISA) designed to detect platelet autoantibodies eluted from patient’s platelets or circulating in the patient’s serum or plasma.

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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.