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uTYPE™ Dx HLA Sequence Analysis Software

ONE LAMBDA, INC. · Model N/A · UDI-DI 00814695021765

MZI Prescription

510(k) clearances

511

Adverse events

Recalls

Facilities

Description

Processes DNA sample data files of Class I and Class II Human Leukocyte Antigens (HLA) for analysis and HLA allele assignment by comparison to the IMGT/HLA database with uTYPE. The sample data files are generated from samples processed with SeCore™ SBT Sequencing kits or GSSP SBT Sequencing kits and the Applied Biosystems Genetic Analyzer.

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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.