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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
Soludiab
Tyson Bioresearch, Inc.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
QUIK-CHECK Cholesterol Control Solution
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
plusMED fasTTest
Tyson Bioresearch, Inc.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
GLUCO TEST Plus Kontrolllösung normal
Taidoc Technology Corporation
·
,
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
GLUCOCARD W Control Solution
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
FINETEST Auto-coding premium Control solution (Normal&High)
OSANG HEALTHCARE Co., Ltd.
·
,
South Korea
IVD Annex II List B
CE/IVDD
CueSee HbA1c - Level 1
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
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
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