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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry controls/standards/calibrators
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Multicomponent immunochemistry controls
Multicomponent immunochemistry controls
W01021521
278 devices
TruVue
BioFynder Limited
·
,
United Kingdom
IVD General
CE/IVDD
Chemiluminescence Immunoassay Multi-analytes (CIM) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Seronorm® Immunoassay Liq L-3
Sero As
·
,
Norway
IVD Annex II List B
CE/IVDD
MAS DOA Total® Liquid Assayed Drugs of Abuse Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Inflammation Markers Control
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
PRE-ECLAMPSIA CONTROL LEVEL 1 (Pre-eclampsia CONTROL 1)
Randox Laboratories Limited
·
,
Northern Ireland
Class C
CE/IVDR
GUDID
on market
Alinity c DOA MC Semiquant Calibrator Kit
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
DRI Negative Urine Calibrator
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
invitrol® Protein liquid L-3
invicon diagnostic concepts GmbH
·
,
Germany
IVD General
CE/IVDD
Fertility Markers Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD General
CE/IVDD
Lung Marker Control
Fujirebio Diagnostics AB
·
,
Sweden
IVD General
CE/IVDD
GUDID
on market
Allergen-Specific IgE Antibody Quality Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Inflammatory Markers Control
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
ARCHITECT DOA MC I Calibrator 3
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
MAS Liquimmune Liquid Assayed Immunoassay Control
Microgenics Corporation
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
Inflammation Markers Control
Zhengzhou Bioyuan Biotech Co. Ltd.
·
,
China
Class C
CE/IVDR
MAS DOA Total® Liquid Assayed Drugs of Abuse Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Cardiopulmonary Markers Controls
Medcaptain Medical Technology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Maternal Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
MAS Liquimmune Liquid Assayed Immunoassay Control
Microgenics Corporation
·
,
United States
IVD Annex II List B
CE/IVDD
GUDID
on market
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