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Radioimmunoassay, Thyroxine-Binding Globulin

FDA product code CEE · Class 2 · Clinical Chemistry

11
Registered devices
0
Adverse events
1
Recalls
25
510(k) clearances

Devices with this code

IMMULITE®/IMMULITE® 1000 Systems TU Thyroid Uptake — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® 2000 Systems TGB TBG Sample Diluent — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDN-TBG AccuBind ELISA Test System - 480 Wells — MONOBIND, INC.N-TBG AccuBind ELISA Test System - 96 Wells — MONOBIND, INC.IMMULITE® 2000 Systems TU Thyroid Uptake — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDMonobind AccuLite TBG CLIA Kit - 96 Wells — MONOBIND, INC.Monobind AccuBind TBG ELISA Kit - 96 Wells — MONOBIND, INC.N-TBG AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.IMMULITE® 2000 Systems TBG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE®/IMMULITE® 1000 Systems TBG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTDIMMULITE® Systems TBG CONTROL — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD

Recent recalls

DateFirmReason
2015-04-09Siemens Healthcare Diagnostics, Inc.IMMULITE/IMMULITE 1000 TBG catalog LKTB lot 257 is failing the adjustment slope instrument parameter of <1.80. The resulting slope of the kit is >1.80 resultin

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