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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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Multiple pathogens - rt & poc
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Other multiple pathogens - rt & poc
Other multiple pathogens - rt & poc
W0105090699
137 devices
Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test (Whole Blood +2 more)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Kit
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19/FluA&B/RSV Ag Combo Rapid Test
InTec PRODUCTS, INC.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2, Influenza A/B, RSV, Adenovirus, M. pneumoniae, hMPV, Rhinovirus, hP…
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
RapidFor™
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDR
CE/IVDD
COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test
Hangzhou Aichek Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multiplex Respiratory Antigen Rapid Test
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Group A Rotavirus & Adenovirus & Norovirus Ag Detection Kit (Immunofluorescence…
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
RapidFor™
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit
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
Bacterial Vaginosis Multi-Test(Swab)
Safecare Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Rotavirus Adenovirus Test
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş.
·
,
Türkiye
IVD General
CE/IVDD
Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
COVID-19&Influenza A/B&RSV&ADV Antigen combo Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class B
CE/IVDR
Rapid Flu A+B/RSV Antigen Test Card
Xiamen Boson Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV…
Dezhou Guoke Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mycoplasma pneumoniae IgM Rapid Test
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
SOFTEC SARS-CoV-2 Neutralizing Antibody Rapid Test
Zet Medi̇kal Teksti̇l Diş Ti̇c. Ltd. Şti̇.
·
,
Türkiye
IVD General
CE/IVDD
Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test
Avioq Bio-tech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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