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In vitro diagnostic medical devices
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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)
Controls/standards/calibrators (blood test strips)
W0101060108
132 devices
Subcategories
2
W010106010801
Blood test strips controls
132
devices
W010106010802
Blood test strips calibrators and standards
0
devices
Devices
SOMA® Glucose Control Solution
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
ELEMENT Blood Glucose Control Solution (Low)
OSANG HEALTHCARE Co., Ltd.
·
,
South Korea
IVD Annex II List B
CE/IVDD
UASure II
Apex Biotechnology Corp.
·
,
Taiwan
IVD for self-testing
FDA 510(k)
K242209
Active
Cleared 4 Apr 2025
CE/IVDD
GLUCO TEST DUO Kontrolllösung normal
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
BeneCheck Uric Acid Control Solution
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD for self-testing
CE/IVDR
IX 2029595-1
Active
Valid to Aug 2030
CE/IVDD
Blood Glucose Control Solution
Changsha Sinocare Inc.
·
,
China
IVD Annex II List B
CE/IVDD
BeneCheck III Glucose Control Solution
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
BeneCheck Uric Acid Control Solution
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD for self-testing
CE/IVDD
BeneCheck II Glucose Control Solution
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Glucose Control Solutions
Bioland Technology Ltd.
·
,
China
Class C
CE/IVDR
V74 051313 0032
Active
Valid to Apr 2030
GUDID
on market
GLUCOCARD W Control Solution
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
Lipid Control Solution
Hangzhou Bosure Biotech Co., Ltd
·
,
China
IVD General
CE/IVDD
Stc
Scienco Technology Corp.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
ELEMENT Blood Glucose Control Solution (High)
OSANG HEALTHCARE Co., Ltd.
·
,
South Korea
IVD Annex II List B
CE/IVDD
CueSee HbA1c - Level 2
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
GLUCOCARD W Control Solution
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
BeneCheck Glucose Control Solution
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
The Edge
Apex Biotechnology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Accugence®
E-Linkcare Meditech Co., Ltd.
·
,
China
IVD General
CE/IVDD
Contrex Plus III
Apex Biotechnology Corp.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
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