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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
Rapid COVID-19 (Antigen) Self-Test
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Simple Rota-Adeno / Stick Rota-Adeno
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
Capilia hMPV Test Plate 10T/Box
TAUNS Laboratories, Inc.
·
,
Japan
IVD General
CE/IVDD
COVID-19 Ag+Flu A/Flu B Rapid Test (Immunochromatography Assay)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab)
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
6188440CE01
Active
Valid to Apr 2030
SARS-CoV-2 IgG Antibody Detection Kit (Colloidal gold method)
Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Neisseria Gonorrheae(NGH) AntigenRapid TestStrip(ColloidalGold)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
2019-nCoV Antigen Rapid Test (Immunochromatography Assay)
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Norovirus/ Rotavirus/ Adenovirus Combo 10 tests / INRA-635
BioMaxima Spółka Akcyjna
·
,
Poland
Class B
CE/IVDR
Adenovirus/RSV Combo Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Lyher
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
Chikungunya IgM Rapid Test
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19 Antigen Rapid Test Kit（Oral Saliva）
Beijing Kewei Clinical Diagnostic Reagent Inc
·
,
China
IVD General
CE/IVDD
SARS-CoV-2/Flu A+B/HPIV2/HPIV1+3/RSV/ADV/MP/SP/HMPV Antigen Rapid Test Kit (Imm…
Bioteke Corporation (Wuxi) Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold)
Shenzhen Zijian Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
biotical Enterovirus Card
Biotical Health S.L.U
·
,
Spain
IVD General
CE/IVDD
HSV IgG/IgM Rapid Test
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Simple RespirAdeno
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
Adenovirus Test
Ameritech Diagnostic Reagent (Jiaxing) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Sienna COVID-19 Antigen Rapid Test Cassette (Saliva / Nasopharyngeal Swab)
Salofa Oy
·
,
Finland
IVD General
CE/IVDD
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