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Cardiolipin IgM ELISA

DRG International Inc · Model EIA-2789 · UDI-DI 00840239027894

DDC Prescription
1
510(k) clearances
1
Adverse events
1
Recalls
12
Facilities

Description

The Cardiolipin IgM ELISA Test System is an enzyme-linked immunosorbent assay (ELISA) designed for the semi- quantitative measurement of circulating IgM autoantibodies to Cardiolipin

Recalls

DateFirmReason
2006-10-26Beckman Coulter IncLow end imprecision affecting both S0 calibrators and patient samples which can lead to inaccurate low level patient results when using the Access Thyroglobulin Antibody assay.

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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.