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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Therapeutic drug monitoring
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Therapeutic drug monitoring - other
Therapeutic drug monitoring - other
W01020899
40 devices
Alprazolam Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
Linezolid CLIA Kit (Chemiluminescence Immunoassay)
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class C
CE/IVDR
5-Fluorouracil CLIA Kit (Chemiluminescence Immunoassay)
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class C
CE/IVDR
ClinMass®
RECIPE Chemicals + Instruments GmbH
·
,
Germany
IVD General
CE/IVDD
Inditreat Crc Explore Array
2cureX A/S
·
,
Denmark
Class C
CE/IVDR
Rifampicin CLIA Kit（Chemiluminescence Immunoassay）
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class C
CE/IVDR
ClinMass®
RECIPE Chemicals + Instruments GmbH
·
,
Germany
IVD General
CE/IVDD
Oncogramme
Oncomedics SAS
·
,
France
IVD General
CE/IVDD
Carisopodol (SOMA) Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
Bevacizumab CLIA kit (Chemiluminescence Immunoassay)
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class C
CE/IVDR
Isoniazid Determination Kit（Fluorescence Immunochromatographic Assay）
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class C
CE/IVDR
Tropicamide Rapid Test
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Zolpidem
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
mAbXmise HTDM
Promise proteomics
·
,
France
Class B
CE/IVDR
Clozapine/Aripiprazole/Risperidone/ Olanzapine Kit(LC-MS/MS)
Jiangxi Medicalsystem Biological Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Nivolumab CLIA kit (Chemiluminescence Immunoassay)
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class C
CE/IVDR
Paclitaxel CLIA Kit (Chemiluminescence Immunoassay)
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class C
CE/IVDR
Trastuzumab CLIA kit (Chemiluminescence Immunoassay)W01020899
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class C
CE/IVDR
mAbXmise PNHTDM
Promise proteomics
·
,
France
Class B
CE/IVDR
Total Risperidone CLIA Kit (Chemiluminescence Immunoassay)
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class C
CE/IVDR
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