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Anti-Thyroglobulin (Anti-Tg) ELISA

DRG International Inc · Model EIA-4110 · UDI-DI 00840239041104

DDC
10
510(k) clearances
1
Adverse events
1
Recalls
12
Facilities

Description

The Quantitative Determination of Thyroglobulin (Tg) Autoantibodies in Human Serum or Plasma by a Microplate Enzyme Immunoassay, Colorimetric. Measurements of Tg autoantibodies may aid in the diagnosis of certain thyroid diseases such as Hashimoto’s and Grave’s as well as nontoxic goiter.

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.