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In vitro diagnostic medical devices
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IVD instruments
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Chemistry / immunochemistry instruments
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Chemistry / immunochemistry rapid tests + poc tests
Chemistry / immunochemistry rapid tests + poc tests
W020106
681 devices
Subcategories
2
W02010601
Diabetes monitoring
410
devices
›
W02010690
Various rapid test chemistry / immunochemistry instruments ("point of care" and/or emergency)
271
devices
›
Devices
Fluorescence Immunoassay Analyzer
Shenzhen Drawray Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
BeneCheck Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Portable Quantitative Immunoassay Analyzer
Hangzhou Realy Tech Co., Ltd.
·
,
China
Class A
CE/IVDR
BeneCheck Uni Premium Harnsäure-Messsystem
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Handheld Fluorescence Immunoassay Analyzer
Shenzhen Drawray Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Qassay Lateral Flow Reader DUAL
P4Q Health S.L.
·
,
Spain
Class A
CE/IVDR
Dry Fluorescence Immunoassay Analyzer
Suzhou Helmen Precision Insturments Co., Ltd
·
,
China
Class A
CE/IVDR
Colloidal Gold Test Analyzer
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class A
CE/IVDR
Semi-Automatic Fluorescence Immunassay Analyzer
Assure Tech. (Hangzhou) Co., Ltd.
·
,
China
Class A
CE/IVDR
Mission Cholesterol Meter
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Pathfast Waste Box
Phc Corporation
·
,
Japan
Class A
CE/IVDR
G6PD Biosensor Test Meter
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
Class A
CE/IVDR
Mini Immunofluorescence Analyzer
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
ProciseDx Analyzer
ProciseDx Inc.
·
,
United States
Class A
CE/IVDR
GUDID
on market
Safe AQ UG
Changsha Sinocare Inc.
·
,
China
IVD Annex II List B
CE/IVDD
Multiplex Fluorescent Analyzer
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Microlife Multiplex Multi-Monitoring System
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
AllDx
Hangzhou Aokai Biotech Co., Ltd.
·
,
China
Class A
CE/IVDR
Chemiluminescence Immunoassay Analyzer
Nanjing Poclight Biotechnology Co., Ltd.
·
,
China
Class A
CE/IVDR
Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip)
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD for self-testing
CE/IVDD
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