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Specific controls (clinical chemistry)
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Diabetes controls
Diabetes controls
W0101050205
87 devices
Devices
Bionime Rightest GC300 Glucose Control Solution
Bionime Corporation
·
,
TW
IVD Annex II List B
FDA 510(k)
K133003
Active
Cleared 24 Oct 2013
CE/IVDD
OneTouch Verio Control Solution
LifeScan Europe GmbH
·
,
CH
IVD Annex II List B
CE/IVDD
Hemoglobin A1C Control (Elevated)
Biosystems S.A.
·
,
ES
IVD General
CE/IVDD
GLUCO TEST DUO Kontrolllösung hoch
Taidoc Technology Corporation
·
,
TW
IVD Annex II List B
CE/IVDD
Z-Hb Confirm HbA1c Control Kit
ZOVEC diagnostics GmbH
·
,
DE
IVD General
CE/IVDD
Blood Glucose Control Solutions
YASEE BioMedical Inc.
·
,
CN
IVD Annex II List B
CE/IVDD
Glycated Hemoglobin A1c Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
HbA1c Control
Shenzhen Lifotronic Technology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
HbA1c Control
Zhejiang Orient Gene Biotech Co., Ltd.
·
,
CN
IVD General
CE/IVDD
OneTouch Verio Control Solution
Lifescan Europe
·
,
CH
IVD Annex II List B
CE/IVDD
Blood Glucose Control Solution_W2
Taidoc Technology Corporation
·
,
TW
IVD Annex II List B
CE/IVDD
Seronorm® HbA1c Liquid L-1
Sero As
·
,
NO
IVD General
CE/IVDD
Glycated Hemoglobin A1c Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
A1c Go HbA1c Control
Goldsite Diagnostics Inc.
·
,
CN
IVD General
CE/MDR
HbA1c Control Kit
Labnovation Technologies, Inc.
·
,
CN
IVD General
CE/IVDD
Glycated Hemoglobin A1c Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
extendSURE™ HbA1c Liquid Controls
Canterbury Scientific, Ltd.
·
,
NZ
IVD General
CE/IVDD
GUDID
on market
MAS Diabetes Liquid Assayed Diabetes Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
A1c Go HbA1c Control
Goldsite Diagnostics Inc.
·
,
CN
IVD General
CE/IVDD
Glycosylated Hemoglobin A1c (HbA1c) Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
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