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Controls/standards/calibrators clinical chemistry
Controls/standards/calibrators clinical chemistry
W010105
1,193 devices
Subcategories
3
W01010501
Multicomponent controls (clinical chemistry)
232
devices
›
W01010502
Specific controls (clinical chemistry)
498
devices
›
W01010503
Calibrators and standards (clinical chemistry)
463
devices
›
Devices
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
HbA1c Control
Shenzhen Lifotronic Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
HbA1c Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
China
IVD General
CE/IVDD
OneTouch Verio Control Solution
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
Blood Glucose Control Solution_W2
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Seronorm® HbA1c Liquid L-1
Sero As
·
,
Norway
IVD General
CE/IVDD
Glycated Hemoglobin A1c Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
A1c Go HbA1c Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
HbA1c Control Kit
Labnovation Technologies, Inc.
·
,
China
IVD General
CE/IVDD
Glycated Hemoglobin A1c Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
extendSURE™ HbA1c Liquid Controls
Canterbury Scientific, Ltd.
·
,
New Zealand
IVD General
CE/IVDD
GUDID
on market
MAS Diabetes Liquid Assayed Diabetes Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
A1c Go HbA1c Control
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
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