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In vitro diagnostic medical devices
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Infectious diseases
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Infectious immunology - rapid tests & point of care
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Bacteriology - rt & poc
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Bacteriology - rt & poc - other
Bacteriology - rt & poc - other
W0105090199
203 devices
Typhoid Rapid Test Kit（Colloidal Gold）
Biobase Poct Co., Ltd
·
,
China
IVD General
CE/IVDD
Brucella IgG/IgM Rapid Test (WB +2 more)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Gonorrhea + Chlamydia Antigen Combo Test Cas-sette
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
TB Tuberculosis Rapid Test Device (Whole Blood +2 more)
Abon Biopharm(Hangzhou) Co., Ltd
·
,
China
IVD General
CE/IVDD
Rapid Leptospira IgG/IgM Combo Test
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Salmonella typhi Antigen Rapid Test Cassette
Hangzhou Alltest Biotech.Co., Ltd.
·
,
China
IVD General
CE/IVDD
biotical Campylobacter Card (+PC +NC)
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
Rapid Salmonella typhi IgG/IgM Duo Test Card
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
H.pylori Antigen Test Kit(Feces)
Neo-nostics (Suzhou) Bioengineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Candida Strip Test
Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
H.pylori Antibody Test Kit (Serum +2 more)
Neo-nostics (Suzhou) Bioengineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Cryptosporidium Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
ReaScan+ C6 LYME IgG
Reagena Oy
·
,
Finland
IVD General
CE/IVDD
TB Combo Test
Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Gardnerella vaginalis Ag Rapid Test Kit
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Neisseria gonorrhoeae Antigen Test Kit
Kangsheng Information Technology (Hangzhou) Co. LTD
·
,
China
IVD General
CE/IVDD
Gardneralla Vaginalis Rapid Test
Kangsheng Information Technology (Hangzhou) Co. LTD
·
,
China
IVD General
CE/IVDD
biotical E. Coli O157:H7 Card (+PC)
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
Gonorrhea + Chlamydia Antigen Combo Test Cassette
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
Tuberculosis (TB) Rapid Test
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
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