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In vitro diagnostic medical devices
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Specific controls (clinical chemistry)
Specific controls (clinical chemistry)
W01010502
498 devices
Subcategories
8
W0101050201
Enzyme controls
53
devices
W0101050202
Lipid controls
39
devices
W0101050203
Bilirubin controls
22
devices
W0101050204
Electrolyte controls
42
devices
W0101050205
Diabetes controls
87
devices
W0101050207
Urine controls
96
devices
W0101050208
Csf controls
6
devices
W0101050299
Specific controls (cc) - other
153
devices
Devices
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
Quality Control Kit
ZOVEC diagnostics GmbH
·
,
Germany
IVD General
CE/IVDD
Blood Gas Analyzer Control
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
SPOTCHEM Electrolyte Control [Na, K, Cl]
ARKRAY Factory, Inc.
·
,
Japan
IVD General
CE/IVDD
Electrolyte Multiple Quality Control (Direct Method)
Medicalsystem Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
GUDID
on market
Electrolyte Control
B&E Bio-Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
ISE Quality Control Material
URIT Medical Electronic Co., Ltd.
·
,
China
Class B
CE/IVDR
Blood Gas Analyzer Control
Guangzhou Wondfo Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
Controls
Edan Instruments, Inc.
·
,
China
IVD General
CE/IVDD
Bionime Rightest GC300 Glucose Control Solution
Bionime Corporation
·
,
Taiwan
IVD Annex II List B
FDA 510(k)
K133003
Active
Cleared 24 Oct 2013
CE/IVDD
OneTouch Verio Control Solution
LifeScan Europe GmbH
·
,
Switzerland
IVD Annex II List B
CE/IVDD
Hemoglobin A1C Control (Elevated)
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
GLUCO TEST DUO Kontrolllösung hoch
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Z-Hb Confirm HbA1c Control Kit
ZOVEC diagnostics GmbH
·
,
Germany
IVD General
CE/IVDD
Blood Glucose Control Solutions
YASEE BioMedical Inc.
·
,
China
IVD Annex II List B
CE/IVDD
Glycated Hemoglobin A1c Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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