Home › Device types › DDC
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
Anti-Thyroglobulin (Anti-Tg) ELISA — DRG International IncAnti-Thyroglobulin (Anti-Tg) ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungAnti-Tg AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Autostat II Anti-Thyroglobulin — HYCOR BIOMEDICAL LLCReQuest — QUEST INTERNATIONAL, INC.Anti-Tg AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.NA — REMEL EUROPE LIMITEDSeraQuest — QUEST INTERNATIONAL, INC.TPO IgG ELISA — DRG International IncCardiolipin IgM ELISA — DRG International IncTPO IgG ELISA — DRG Instruments Gesellschaft mit beschränkter HaftungNA — REMEL EUROPE LIMITEDQUANTA Lite® Thyroid T ELISA — INOVA DIAGNOSTICS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2006-10-26 | Beckman Coulter Inc | Low 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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