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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
Apolipoprotein A1 & B control M
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
Multiple Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
AEA IgG POSITIVE CONTROL
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
IL-6 Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Specific Protein Control
Medicalsystem Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HbA1c CONTROL L + H
Vitalscientific
·
,
France
Class B
CE/IVDR
GUDID
on market
ASA-bm POSITIVE CONTROL
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Alpha2-macroglobulin urine controls L
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
IL-6 Control
Healgen Scientific Limited Liability Company
·
,
United States
IVD General
CE/IVDD
Multiparametric controls H
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
Crp Ip Control I
Vitalscientific
·
,
France
Class B
CE/IVDR
Specific Protein Control
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Vigil Lipid Control Level 4
Beckman Coulter, Inc.
·
,
United States
Class B
CE/IVDR
GUDID
on market
Alpha2-macroglobulin urine controls H
Diagam S.A.
·
,
Belgium
IVD General
CE/IVDD
Myxovirus Resistance Protein A Control Solution (FIA)
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Vigil Protein Control Level 3
Beckman Coulter, Inc.
·
,
United States
Class C
FDA 510(k)
K982224
Active
Cleared 9 Jul 1998
CE/IVDR
+1
authorizations
Specific Protein Control
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
SAA Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Finecare
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
C-Reactive Protein Control
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
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