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Lambda Antigen Tray™ Class I - 1 test tray

ONE LAMBDA, INC. · Model N/A · UDI-DI 00812117012452

MZI Prescription
0
510(k) clearances
511
Adverse events
0
Recalls
7
Facilities

Description

The assay is designed for detection of potentially detrimental antibody against HLA antigens in the serum of pre- and post-transplant organ recipients.

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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.