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In vitro diagnostic medical devices
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Infectious diseases
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Multiple parameters - (infect. immunology/nat)
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Multiple bacteria / fungi panels
Multiple bacteria / fungi panels
W01050702
118 devices
Subcategories
3
W0105070201
Gram+ - gram- - fungi - multiplex na reagents
31
devices
W0105070202
Blood stream infection/sepsis (bacteria & fungi) - multiplex na reagents
58
devices
W0105070203
Gram+ - gram- - fungi - multiplex assays
29
devices
Devices
Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-…
Sansure Biotech Inc.
·
,
CN
Class C
CE/IVDR
CE/IVDD
ESKAPE Multipathogenic Nucleic Acid Test Kit (Fluorescent PCR Method)
RocGene (Xuzhou) Technology Limited
·
,
CN
IVD General
CE/IVDD
iSolutions™ Enteric Bacteria & C. difficile Fullplex qPCR
Id Solutions
·
,
FR
IVD General
CE/IVDD
Respiratory Bacterial Panel Strip
Operon, S.A.
·
,
ES
IVD Annex II List B
CE/IVDD
Blood pathogens and drug resistance genes digital PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
CN
IVD General
CE/IVDD
Blood pathogens and drug resistance genes real-time PCR detection kit
TargetingOne Technology (Beijing) Corporation
·
,
CN
IVD General
CE/IVDD
ChainFor™
Vitrosens Biotechnology Inc.
·
,
TR
IVD General
CE/IVDD
ChainFor Wound ID-30 Genotyping qPCR Kit
Vitrosens Biotechnology Inc.
·
,
TR
IVD General
CE/IVDD
Dermatophyte Nucleic Acid Test Kit (Fluorescent PCR Method)
RocGene (Xuzhou) Technology Limited
·
,
CN
IVD General
CE/MDR
Six Carbapenem-resistant Gene Nucleic Acid Test Kit (PCR-Fluorescent Probe Meth…
RocGene (Xuzhou) Technology Limited
·
,
CN
IVD General
CE/IVDD
Shigella/Entamoeba histolytica Nucleic Acid Detection Kit (Fluorescence)
Kangsheng Information Technology (Hangzhou) Co. LTD
·
,
CN
IVD General
CE/IVDD
Dermatophyte Nucleic Acid Test Kit (Fluorescent PCR Method)
RocGene (Xuzhou) Technology Limited
·
,
CN
IVD General
CE/IVDD
Six Carbapenem-resistant Gene Nucleic Acid Test Kit (PCR-Fluorescent Probe Meth…
RocGene (Xuzhou) Technology Limited
·
,
CN
IVD General
CE/IVDD
QIAstat-Dx BCID GPF Plus AMR Panel
QIAGEN GmbH
·
,
DE
Class C
CE/IVDR
Multiple Invasive Fungal Nucleic Acid Test Kit (Fluorescent PCR Method)
RocGene (Xuzhou) Technology Limited
·
,
CN
IVD General
CE/IVDD
Six Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-…
Sansure Biotech Inc.
·
,
CN
IVD General
CE/IVDD
Six Candida Species Nucleic Acid Detection Kit (Digital PCR Method)
Pilot Gene Technology (Hangzhou) Co., Ltd
·
,
CN
IVD General
CE/IVDD
Shigella/Entamoeba histolytica Nucleic Acid Detection Kit
Kangsheng Information Technology (Hangzhou) Co. LTD
·
,
CN
IVD General
CE/IVDD
Five Candida Nucleic Acid Test Kit (Fluorescent PCR Method)
RocGene (Xuzhou) Technology Limited
·
,
CN
IVD General
CE/IVDD
ESKAPE Multipathogenic Nucleic Acid Test Kit (Fluorescent PCR Method)
RocGene (Xuzhou) Technology Limited
·
,
CN
IVD General
CE/IVDD
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