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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
HbA1c Control
Coei Biotech Co.Ltd.
·
,
China
IVD General
CE/IVDD
SYNCHRON Systems 40 ng/mL THC Urine Control
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Inflammatory Markers Control
Beijing Diagreat Biotechnologies Co., Ltd.
·
,
China
Class B
CE/IVDR
Thyroid Autoantibodies Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
Negative Control
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Kemilo IL-6 Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
Thyroid autoantibodies Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
SARS-CoV-2 Ag Control
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
ImmunoCAP Specific IgE Control L
Phadia AB
·
,
Sweden
Class B
FDA 510(k)
K131738
Active
Cleared 10 Jul 2013
CE/IVDR
+1
authorizations
IDS-iSYS 25 VitDS Control Set
Immunodiagnostic Systems Limited
·
,
United Kingdom
Class B
FDA 510(k)
K161831
Active
Cleared 15 Nov 2016
CE/IVDR
+1
authorizations
i-Track 10 Cartridge Check System
Immunodiagnostic Systems SA
·
,
Belgium
Class A
CE/IVDR
1, 25-(OH)2-Vitamin D3/D2 Control Set
Immundiagnostik AG
·
,
Germany
Class B
CE/IVDR
Infectious Diseases Control Solution (FIA)
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
PathTROL Allergy Control - Level 2
Eurobio Scientific UK Ltd
·
,
United Kingdom
IVD General
CE/IVDD
H.Pylori Ag Control
Coei Biotech Co.Ltd.
·
,
China
IVD General
CE/IVDD
Thyroid Function Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
KEYU Calprotectin Quality Control (Quantitative)
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
China
IVD General
CE/IVDD
Thyroid Speciality Control
Autobio Diagnostics Co., Ltd.
·
,
China
Class B
CE/IVDR
Thyroid Function Control
Maccura Biotechnology Co., Ltd.
·
,
China
Class B
CE/IVDR
Kemilo PCT Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
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