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In vitro diagnostic medical devices
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Clinical chemistry
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Clinical chemistry - rapid tests & poc
Clinical chemistry - rapid tests & poc
W010106
2,150 devices
Subcategories
6
W01010601
Blood test strips (cc) - rt & poc
839
devices
›
W01010602
Urine testing (cc) - rt & poc
982
devices
›
W01010603
Faeces tests (cc) - rt & poc
82
devices
›
W01010604
Multiple parameters poc
45
devices
›
W01010606
Electrodes or cassettes for blood gas analysis incl. electrolytes / metabolites - poc
163
devices
›
W01010699
Clin. chem. rt & poc - other
39
devices
Devices
plusMED fasTTest
Tyson Bioresearch, Inc.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
BeneCheck II Glucose Control Solution
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Mission Cholesterol Control Solution
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
OGCare Control Solution
Biochemical Systems International S.p.A.
·
,
Italy
IVD Annex II List B
CE/IVDD
BeneCheck β-Ketone Control Solution
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD for self-testing
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/IVDR
IX 2029595-1
Active
Valid to Aug 2030
CE/IVDD
Blood Glucose Monitoring System Control Solution
URIT Medical Electronic Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
GLUCOCARD W Control Solution
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
BeneCheck Total Cholesterol Control Solution
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD for self-testing
CE/IVDD
smartLAB® Glucose Control Solution
Eps Bio Technology Corp.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Lipid Control Solution
Changsha Sinocare Inc.
·
,
China
IVD General
CE/IVDD
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
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