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In vitro diagnostic medical devices
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Infectious diseases
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Bacteriology (infect. immunology/nat)
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Mycobacteria genus + species
Mycobacteria genus + species
W01050107
196 devices
Subcategories
5
W0105010701
Mycobacterial antigen detection
1
device
W0105010702
Mycobacterial antibody assays
17
devices
W0105010703
Mycobacterial detection by na reagents
108
devices
W0105010704
Tb-igra (interferon-gamma-release assay)
13
devices
W0105010799
Mycobacteria reagents - other
57
devices
Devices
Mycobacterium Tuberculosis Complex Fluorescence PCR Kit (Lyophilized)
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
ANDiS MTB RIF/INH Resistance Detection Kit
3D Biomedicine Science & Technology Co., Limited
·
,
China
IVD General
CE/IVDD
RealAccurate® Quadruplex Mycobacteria PCR kit
PathoFinder B.V.
·
,
Netherlands
IVD General
CE/IVDD
Diagnostic Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence)
Daan Gene Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mycobacterium Tuberculosis Nucleic Acid Detection Kit (Fluorescent PCR)
Triplex International Biosciences (China) Co., LTD.
·
,
China
IVD General
CE/IVDD
FluoroType® MTBDR VER 2.0
Hain Lifescience GmbH
·
,
Germany
Class C
CE/IVDR
GeneStream MTB Assay
Hangzhou Danwei Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
FlashDetect
Coyote Bioscience Co., Ltd.
·
,
China
IVD General
CE/IVDD
Anyplex™ MTB/NTMe Real-time Detection
Seegene Inc.
·
,
South Korea
IVD General
CE/IVDD
Mycobacterium Tuberculosis and Drug-resistant Gene Nucleic Acid Testing Kit(PCR…
Singuway Biotech Inc.
·
,
China
IVD General
CE/IVDD
PowerChek™ MTB/NTM Real-time PCR Kit
KogeneBiotech Co., Ltd.
·
,
South Korea
IVD General
CE/IVDD
GeneStream MTB/RIF Assay
Hangzhou Danwei Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
M.tuberculosis Drug Resistance Detection Array Kit
CapitalBio Technology (Chengdu) Co., Ltd.
·
,
China
IVD General
CE/IVDD
MycoMDx Mycobacterium tuberculosis complex nucleic acid test kit (F-PCR)
Dynamiker Biotechnology (Tianjin) Co., Ltd.
·
,
China
IVD General
CE/IVDD
NTM Drug Resistance Gene Mutation Detection Kit(Fluorescence PCR Melting Curve …
Zhuhai Encode Medical Engineering Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mycobacteria Identification Kit (MMCA)
Xiamen Zeesan Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Diagnostic Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence)
Daan Gene Co., Ltd.
·
,
China
IVD General
CE/IVDD
MTB/SL Test Kit (MMCA)
Xiamen Zeesan Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Detection Kit for Mycobacterium Tuberculosis Complex Nucleic Acid (PCR-Fluoresc…
Daan Gene Co., Ltd.
·
,
China
IVD General
CE/IVDD
Mycobacterium Tuberculosis Complex Nucleic Acid Detection Kit (Fluorescence PCR…
Suzhou TianLong Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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