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EliA IgA Calibrators

Phadia AB · Model 83-1013-01 · UDI-DI 07333066020075

MVM Prescription
1
510(k) clearances
2
Adverse events
1
Recalls
19
Facilities

Description

Contains one vial of each Calibrator (Cal-0, Cal-0.3, Cal-1.5, Cal-5, Cal-15, Cal-80) to form a complete calibration curve for EliA IgA method.

Recalls

DateFirmReason
2019-04-03Bio-Rad LabsAn elevated lot-to-lot bias was observed for Autoimmune EIA Anti-Tissue Transglutaminase (tTG) IgA when compared to a previous lot of product. The observed elevated bias between th

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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.