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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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Controls - immunochemistry
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Specific protein controls
Specific protein controls
W0102152003
285 devices
Apca Positive Control
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
SHBG Control
Shenzhen Ever-Blue Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
Beta2-MG Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Apo A1 Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Specific Protein Control
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
B·R·A·H·M·S TRAK human KRYPTOR QC
B.R.A.H.M.S GmbH
·
,
Germany
Class B
CE/IVDR
Vigil Serology Control Level 3
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
GUDID
on market
Calprotectin Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Gastrin-17 Control
Shenzhen Yhlo Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
HbA1c control, 4 x 0.5 mL
Chronolab Systems, S.L.
·
,
Spain
IVD General
CE/IVDD
Multiparametric controls H
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
Vigil Protein Control Level 1
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDD
CE/IVDR
+1
authorizations
CysC Control
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
PCT Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Apo A1/B Control LEV1
Medicon Hellas SA
·
,
Greece
IVD General
CE/IVDD
CRP Control M
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Fecal Calprotectin (Fcal) Controls
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Rbp Control
Medicon Hellas SA
·
,
Greece
Class B
CE/IVDR
Urine IgG Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
CRP Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
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