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In vitro diagnostic medical devices
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Reagents
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Infectious diseases
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Infectious immunology - rapid tests & point of care
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Multiple pathogens - rt & poc
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Other multiple pathogens - rt & poc
Other multiple pathogens - rt & poc
W0105090699
137 devices
Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test
Avioq Bio-tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rotavirus-Adenovirus-Astrovirus-Norovirus Combo Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class B
CE/IVDR
ViraxClear Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hiso…
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cass…
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Lyher
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
Ama Venera
«Association of Medicine and Analytics» Company Limited
·
,
Russia
IVD General
CE/IVDD
Rotavirus Adenovirus Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD General
CE/IVDD
Simple RSV-Flu A+B
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
Simple RSV-Flu A+B
Operon, S.A.
·
,
Spain
Class B
CE/IVDR
Rotavirus Adenovirus Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD General
CE/IVDD
Lyher
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test
Avioq Bio-tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Lyher
Hangzhou Laihe Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
Rotavirus Adenovirus Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD General
CE/IVDD
COVID-19/Flu A/Flu B/RSV/ADV/M.P Ag Combo Rapid Test Cassette (Swab)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
StrongStep® System Device for SARS-CoV-2, Influenza A/B & RSV Combo Antigen Rap…
Nanjing Liming Bio-products Co. Ltd
·
,
China
IVD General
CE/IVDD
C. difficile Toxin A/B Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class B
CE/IVDR
RSV & ADV Ag Detection Kit (Immunofluorescence Chromatography)
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19/RSV/Flu A+B Ag Rapid Test
GenSure Biotech Inc.
·
,
China
Class C
CE/IVDR
×2
Active
Valid to Jan 2031
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