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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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Other virology rt & poc
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Virology - rt & poc - other
Virology - rt & poc - other
W0105099099
641 devices
COVID-19 Antigen Rapid Test Cassette (Colloidal Gold )
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Monkeypox Virus IgM/IgG Test Kit (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rotavirus & Adenovirus Rapid Test
Shenzhen Kang Sheng Bao Bio-Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Parainfluenza Virus IgM Rapid Test Kit (Colloidal Gold)
Biobase Poct Co., Ltd
·
,
China
IVD General
CE/IVDD
2019-nCoV Antigen Saliva Rapid Test (Immunochromatography Assay)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Zika Test Device (Serum +2 more)
Neo-nostics (Suzhou) Bioengineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Influenza type A and B(Flu A/B) Ag Rapid Test Cassette(Colloidal Gold)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rapid SARS-CoV-2 Antigen Test Card
BioDetect（Xiamen）Biotechnology Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
RSV+Adeno-resp.+Influenza A+B kas. 20 t.
BioMaxima Spółka Akcyjna
·
,
Poland
Class B
CE/IVDR
COVID-19(SARS-CoV-2) Antigen Test Kit
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
2019-Novel Coronavirus(2019-nCoV) IgG/IgM GICA Rapid Test
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
biotical Adeno Intestinal Card (+PC +NC)
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
EZER COVID-19 Antigen Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD for self-testing
CE/IVDD
Simple Rota-Adeno-Noro
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
HPIV Antigen Rapid Test (Immunochromatographic Assay)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 Salivary Antigen Rapid Test Kit (Colloidal Gold)
Jiangsu Konsung Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 IgG Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
Simple Rota-Adeno / Stick Rota-Adeno
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
COVID-19 Antigen Detection Kit-Nasal swab
New Gene (Hangzhou) Bioengineering Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Rotavirus-Adenovirus-Astrovirus Combo Rapid Test (Feces)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
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