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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Thyroid function hormones
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Free thyroxine
Free thyroxine
W01020402
160 devices
Aia-Pack FT4 Calibrator Set
Tosoh Corporation
·
,
Japan
IVD General
CE/IVDD
GUDID
on market
Free Thyroxine (fT4) Detection Kit(Fluorescence Immunoassay)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Free T4 Test (Fluorescence Immunoassay)
Huzhou Jierunxin Biotechnology Co., LTD
·
,
China
IVD General
CE/IVDD
Free Thyroxine Assay kit(Chemiluminescence Immunoassay Method）
Shenzhen Dake Medical Technology Co., Ltd
·
,
China
Class B
CE/IVDR
iFlash-FT4
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
iFlash-FT4
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
FT4 Assay Kit (Fluorescence Immunoassay)
DiYaLab ZJG Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
FT4 (Clia)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Free Thyroxine (fT4) Detection Kit(CLIA)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
Free Thyroxine（FT4）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoas…
Biobase Diagnostic Technology (Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
FT4 CLIA Microparticles
Autobio Diagnostics Co., Ltd.
·
,
China
Class B
CE/IVDR
FT4 Ria Kit
IMMUNOTECH s.r.o.
·
,
Czechia
Class B
CE/IVDR
Innodx FT4 Cmia
Xiamen Innodx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
FREND Free T4
NanoEnTek, Inc.
·
,
South Korea
IVD General
CE/IVDD
GUDID
on market
Access Free T4
Beckman Coulter, Inc.
·
,
United States
Class B
FDA 510(k)
K240273
Active
Cleared 6 Mar 2024
CE/IVDR
+1
authorizations
Innodx FT4 Cmia
Xiamen Innodx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
FT4 (Clia)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Free Thyroxine (FT4) Test Kit (Immunofluorescence)
Shenzhen Huiyan Sci-Tech Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Free Thyroxine Chemiluminescence Immunoassay Kit
Nanjing RealMind Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Innodx FT4 Cmia
Xiamen Innodx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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