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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
Pathtrol™ Tryptase High Positive Control
Eurobio Scientific UK Ltd
·
,
United Kingdom
IVD General
CE/IVDD
H.Pylori Antibody Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
KEYU Hemoglobin Quality Control (Quantitative)
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
China
IVD General
CE/IVDD
Finecare
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
IDS-iSYS 1, 25-Dihydroxy Vitamin D Control Set
Immunodiagnostic Systems Limited
·
,
United Kingdom
IVD General
FDA 510(k)
K123253
Active
Cleared 18 Jun 2013
CE/IVDD
+1
authorizations
Rotavirus Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Dengue Control
Wuhan Easydiagnosis Biomedicine Co., Ltd.
·
,
China
IVD General
CE/IVDD
Serum Bone Marker Level 3 Control (Serum Bone Marker Control 3)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
Thyroid Function Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
HAV Ab (Liquid) Control
Xiamen Innodx Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Immunochemistry Systems Level 2 Urine Protein Control
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Access SHBG QC
Beckman Coulter, Inc.
·
,
United States
Class B
FDA 510(k)
K233480
Active
Cleared 8 Feb 2024
CE/IVDR
+1
authorizations
Microalbumin Control
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Cormay Microalbumin Control
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
Norovirus Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Pathtrol™ Tryptase Positive Control
Eurobio Scientific UK Ltd
·
,
United Kingdom
IVD General
CE/IVDD
System Wash
DiYaLab ZJG Biotech Co., Ltd
·
,
China
Class A
CE/IVDR
IDS Total IgE Control Set
Immunodiagnostic Systems Limited
·
,
United Kingdom
IVD General
CE/IVDD
Pathtrol™ Allergy Control Level 1 & 2 (Trial Pack)
Eurobio Scientific UK Ltd
·
,
United Kingdom
IVD General
CE/IVDD
Immunoassay Multi Control
Shenzhen Ever-Blue Biotech Co., Ltd.
·
,
China
Class C
CE/IVDR
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