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In vitro diagnostic medical devices
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Fertility function hormones / proteins
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Testosterone (with dehydro and free testosterone)
Testosterone (with dehydro and free testosterone)
W0102050110
184 devices
Testosterone (CLIA)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
free TESTO (eCLIA)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Testosterone (CLIA)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
free TESTO (eCLIA)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Testosterone (TESTO) Assay Kit (Chemiluminescent Immunoassay)
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
·
,
China
IVD General
CE/IVDD
Testosterone
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Testosterone Test Kit (CLIA)
Healgen Life Science LLC
·
,
United States
IVD General
CE/IVDD
Evidence MultiSTAT Testosterone
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
Testosterone (Testo) Quantitative Test Kit(Chemiluminescent Immunoassay, CLIA)
Jiangsu Confidence Medical Technology Co., Ltd
·
,
China
IVD General
CE/IVDD
Testosterone (TESTO) Assay Kit (Chemiluminescent Immunoassay)
Wuhan Life Origin Biotech Joint Stock Co., Ltd.
·
,
China
IVD General
CE/IVDD
CrinoCheck TES Quantitativer Schnelltest (Fluoreszenz Immunoassay)
Xiamen Biotime Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Testosterone Kit (Microfluidic Fluorescent Immunoassay)
Hunan Kangxin Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Testosterone FIA
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
Testosterone test (Chemiluminescence Immunoassay)
Beijing Hotgen Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
Hokapi™ Testosterone
Suzhou Hokapi Biomedical Engineering Co., Ltd..
·
,
China
Class B
CE/IVDR
RIA Testosterone
IMMUNOTECH s.r.o.
·
,
Czechia
Class B
CE/IVDR
Testosterone（T）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)
Biobase Diagnostic Technology (Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Free Testosterone Chemiluminescence Immunoassay Kit
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
Testosterone (Electrochemiluminescence Immunoassay)
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Testosterone Reagent Set
Diagnotix B.V.
·
,
Netherlands
IVD General
CE/IVDD
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