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Thyroglobulin, Antigen, Antiserum, Control

FDA product code DDC · Class 2 · Immunology

13
Registered devices
1
Adverse events
1
Recalls
13
510(k) clearances

Devices with this code

ReQuest — QUEST INTERNATIONAL, INC.Anti-Tg AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.NA — REMEL EUROPE LIMITEDTPO IgG ELISA — DRG International IncQUANTA Lite® Thyroid T ELISA — INOVA DIAGNOSTICS, INC.SeraQuest — QUEST INTERNATIONAL, INC.TPO IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAnti-Thyroglobulin (Anti-Tg) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAnti-Tg AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.NA — REMEL EUROPE LIMITEDAutostat II Anti-Thyroglobulin — HYCOR BIOMEDICAL LLCAnti-Thyroglobulin (Anti-Tg) ELISA — DRG International IncCardiolipin IgM ELISA — DRG International Inc

Recent 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

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.