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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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Controls- immunochemistry - other
Controls- immunochemistry - other
W0102152099
219 devices
Thyroid Function Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
Thyroid Speciality Control
Autobio Diagnostics Co., Ltd.
·
,
China
Class B
CE/IVDR
HA Control
Shenzhen Ever-Blue Biotech Co., Ltd.
·
,
China
Class B
CE/IVDR
H.Pylori Antigen Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Thyroid Function Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
Anti-H. Pylori Control
Neomedica Doo Niš
·
,
Serbia
IVD General
CE/IVDD
Access PAPP-A QC
Immunotech SAS
·
,
France
Class C
CE/IVDR
Dengue IgM/IgG Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Evo Specific Control E
Abd SRL
·
,
Italy
Class A
CE/IVDR
Negative Control
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Access Ostase QC
Beckman Coulter, Inc.
·
,
United States
Class B
FDA 510(k)
×2
K994277
Active
Cleared 14 Jan 2000
CE/IVDR
+1
authorizations
ImmunoCAP Specific IgG/IgG4 i1 Control H
Phadia AB
·
,
Sweden
Class B
CE/IVDR
Adenovirus Control
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Thyroid Function Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
SAA Control
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Dirui
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Mercodia Diabetes Antigen Control (Low, High) / Human
Mercodia Ab
·
,
Sweden
IVD General
CE/IVDD
Adenovirus Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Evo Specific Control G
Abd SRL
·
,
Italy
Class A
CE/IVDR
ImmunoCAP Specific IgE Control M
Phadia AB
·
,
Sweden
Class B
CE/IVDR
GUDID
on market
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