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In vitro diagnostic medical devices
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Reagents
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Infectious diseases
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Multiple parameters - (infect. immunology/nat)
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Multiple panels for infections - various
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Multiple infectious - multiplex assays - other
Multiple infectious - multiplex assays - other
W0105070599
65 devices
Dynamiker HRV / HMPV / MP / ADV Antigens Combo Test Kit（LFA）
Dynamiker Biotechnology (Tianjin) Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 & Flu & RSV Antigen Combo Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
RapidFor™ Vaginal pH Test
Vitrosens Biotechnology Inc.
·
,
Türkiye
IVD General
CE/IVDD
Rheumatoid Factor/Anti-Cyclic Citrullinated Peptide Antibody/Antistreptolysin O…
Chongqing Juce Life Health Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Bacterial Vaginosis combo Test (H2O2 +5 more)
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
mariPOC® RTI combi+ test plate
ArcDia International Oy Ltd
·
,
Finland
IVD General
CE/IVDD
Bacterial Vaginosis combo Test (H2O2 +3 more)
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Respiratory 3 Panel
GeneFirst Limited
·
,
United Kingdom
IVD General
CE/IVDD
mariPOC® Quick combi+ test plate
ArcDia International Oy Ltd
·
,
Finland
IVD General
CE/IVDD
Procalcitonin/C-Reactive Protein/Serum Amyloid A Test Kit (QDs-FICA)
Chongqing Juce Life Health Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Respiratory 1 Panel
GeneFirst Limited
·
,
United Kingdom
IVD General
CE/IVDD
Invasive Fungal Nucleic Acid Detection Kit (Digital PCR Method)
Pilot Gene Technology (Hangzhou) Co., Ltd
·
,
China
IVD General
CE/IVDD
Meningitis/Encephalitis (ME) pathogens digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
i-GFBP-1+FFN three line Combo Rapid Test
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Flu & COVID-19 Antigen Combo Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
Mycoplasma genitalium/Mycoplasma hominis/Trichomonas vaginalis Nucleic Acid Dia…
Sansure Biotech Inc.
·
,
China
IVD General
CE/IVDD
Meningitis/Encephalitis (ME) pathogens digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 & Flu & RSV & ADV Antigen Combo Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD General
CE/IVDD
EZER Flu & COVID-19 Antigen Duo Rapid Test
Hangzhou Genesis Biodetection & Biocontrol Co., LTD.
·
,
China
IVD for self-testing
CE/IVDR
CE/IVDD
Bacterial Vaginosis combo Test (H2O2 +5 more)
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
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