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In vitro diagnostic medical devices
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Clinical chemistry
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Clinical chemistry - rapid tests & poc
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Blood test strips (cc) - rt & poc
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Controls/standards/calibrators (blood test strips)
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Blood test strips controls
Blood test strips controls
W010106010801
132 devices
Devices
CueSee HbA1c - Level 3
Eurotrol B.V.
·
,
NL
IVD General
CE/IVDD
GLUCOCARD W Control Solution
ARKRAY Factory, Inc.
·
,
JP
IVD Annex II List B
CE/IVDD
BeneCheck β-Ketone Control Solution
General Life Biotechnology Co., Ltd.
·
,
TW
IVD for self-testing
CE/IVDD
BeneCheck Uric Acid Control Solution
General Life Biotechnology Co., Ltd.
·
,
TW
IVD for self-testing
CE/MDR
GLUCOCARD S Control Solution
ARKRAY Factory, Inc.
·
,
JP
IVD Annex II List B
CE/IVDD
TruGlyc
BioFynder Limited
·
,
GB
IVD General
CE/IVDD
EASYMAX® Glucose Control Solution
Eps Bio Technology Corp.
·
,
TW
IVD for self-testing
CE/IVDD
MultiSure GK
Apex Biotechnology Corp.
·
,
TW
IVD Annex II List B
CE/IVDD
QUIK-CHECK Ultra Hemoglobin Control Solution
Acon Biotech (Hangzhou) Co., Ltd.
·
,
CN
IVD for self-testing
CE/IVDD
Glucose Control Solutions
Bioland Technology Ltd.
·
,
CN
Class C
CE/IVDR
V74 051313 0032
Active
Valid to Apr 2030
GUDID
on market
BeneCheck II Total Cholesterol Control Solution
General Life Biotechnology Co., Ltd.
·
,
TW
IVD for self-testing
CE/IVDR
IX 2029595-1
Active
Valid to Aug 2030
CE/IVDD
MulticareIN Glucose Control Solution - ITA / ENG
Biochemical Systems International S.p.A.
·
,
IT
IVD Annex II List B
CE/IVDD
BeneCheck β-Ketone Control Solution
General Life Biotechnology Co., Ltd.
·
,
TW
IVD for self-testing
CE/MDR
BeneCheck Uric Acid Control Solution
General Life Biotechnology Co., Ltd.
·
,
TW
IVD for self-testing
CE/IVDR
IX 2029595-1
Active
Valid to Aug 2030
CE/IVDD
GLUCOCARD W Control Solution
ARKRAY Factory, Inc.
·
,
JP
IVD Annex II List B
CE/IVDD
BeneCheck II Total Cholesterol Control Solution
General Life Biotechnology Co., Ltd.
·
,
TW
IVD for self-testing
CE/IVDR
IX 2029595-1
Active
Valid to Aug 2030
CE/IVDD
Solution de contrôle pour la glycémie Vivachek Ino
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
CN
IVD General
CE/IVDD
On Call Extra Glucose Control Solution
Acon Biotech (Hangzhou) Co., Ltd.
·
,
CN
IVD Annex II List B
CE/IVDD
GDH Glucose control solution
Leison Biotech Co., Ltd.
·
,
TW
IVD for self-testing
CE/IVDD
EASYMAX® Glucose Control Solution
Eps Bio Technology Corp.
·
,
TW
IVD for self-testing
CE/IVDD
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