Home › Device types › CDX
Radioimmunoassay, Total Thyroxine
FDA product code CDX · Class 2 · Clinical Chemistry
38
Registered devices
100
Adverse events
1
Recalls
121
510(k) clearances
Devices with this code
Elecsys T4 — Roche Diagnostics GmbHT4 AccuLite CLIA Test System - 960 Wells — MONOBIND, INC.T4 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.T4 SBS AccuLite CLIA Test System - 192 Wells — MONOBIND, INC.T4 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.T4 AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.N-T4 AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.T4 AccuBind ELISA Test System - 960 Wells — MONOBIND, INC.Atellica IM T4 DIL — Siemens Healthcare Diagnostics Inc.Monobind AccuLite T4 CLIA Kit - 192 Wells — MONOBIND, INC.ADVIA Centaur® T4 — Siemens Healthcare Diagnostics Inc.AutoDELFIA Neonatal Thyroxine (T4) kit — Wallac OyN-T4 AccuBind ELISA Test System - 1920 Wells — MONOBIND, INC.Mycoplasma hominis IgG ELISA — DRG International IncTotal T4 MAb 125I RIA Kit — MP BIOMEDICALS, LLCN-T4 AccuBind ELISA Test System - 960 Wells — MONOBIND, INC.T4 SBS AccuLite CLIA Test System - 96 Wells — MONOBIND, INC.Atellica IM T4 — Siemens Healthcare Diagnostics Inc.N-T4 AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.Elecsys T4 Assay — Roche Diagnostics GmbHDELFIA Neonatal Thyroxine (T4) kit — Wallac OyN-T4 AccuBind ELISA Test System - 480 Wells — MONOBIND, INC.T4 SBS AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.QMedix™ — Diagnostic Automation, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-06-04 | DRG International, Inc. | An incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and cont |
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