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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
Devices
Down Syndrome Markers Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
MAS Immunology Liquid Assayed Immunology Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
MAS DOA Total® Liquid Assayed Drugs of Abuse Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDR
CE/IVDD
+1
authorizations
FIT NS-Prime Control
Alfresa Pharma Corporation
·
,
JP
Class C
CE/IVDR
Allergen-Specific IgE Antibody Quality Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
ARCHITECT Tox Calibrators 3
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
Inflammation Markers Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
CN
IVD General
CE/IVDD
CEDIA Cardiac TDM Multi-Calibrators
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Thyroid Funciton Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Hypertension Marker Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Quality Control (TSH +2 more)
Nanjing Vazyme Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
D-Dimer/ cTnI/ NT-proBNP Control
Shenzhen Superbio Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
ARCHITECT DOA MC I Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
Quality Control (TT3/TT4)
Nanjing Vazyme Medical Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
DRI Multi-Drug Urine Calibrator 1
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
MAS DOA Total® Liquid Assayed Drugs of Abuse Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
Down Syndrome Markers Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/MDR
invitrol® CSF liquid Kombi
invicon diagnostic concepts GmbH
·
,
DE
IVD General
CE/IVDD
DRI Multi-Drug Urine Calibrator 2
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
DRI Negative Alcohol Calibrator
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
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