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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
Down Syndrome Markers Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
MAS Immunology Liquid Assayed Immunology Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
DRI Serum Tox Calibrator 2
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Multiple Tumor Marker Quality Control
Sichuan Orienter Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Inflammatory Markers Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Thyroid Function Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
ASO/CRP/RF control H, 4 x 1 mL
Chronolab Systems, S.L.
·
,
Spain
IVD General
CE/IVDD
Chemiluminescence Immunoassay Multi-analytes (CIM) Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
Liver Fibrosis Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
cTnl/ Myo/ CK-MB Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
DRI Drugs of Abuse Low Calibrator
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Hypertension Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Chemiluminescence Immunoassay Multi-analytes (CIM) Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
CanChek Tumor Marker Control
Fujirebio Diagnostics AB
·
,
Sweden
IVD General
FDA 510(k)
K103676
Active
Cleared 19 Jul 2011
CE/IVDD
Endocrine Control II
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
SERO Maternal Health® Control - Early
Sero As
·
,
Norway
IVD Annex II List B
CE/IVDD
cTnl/ Myo/ CK-MB Control
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Thyroid Function Multi Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
MAS PAR TDM Liquid Assayed Therapeutic Drug Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
B·r·a·h·m·s Gm Kryptor Qc
B.R.A.H.M.S GmbH
·
,
Germany
Class C
CE/IVDR
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