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In vitro diagnostic medical devices
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Reagents
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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
Ime-Dc
Scienco Technology Corp.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
Wellion AMADEUS
Apex Biotechnology Corp.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
VivaChek Fad Control Solution
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
BeneCheck Total Cholesterol Control Solution
General Life Biotechnology Co., Ltd.
·
,
Taiwan
IVD for self-testing
CE/IVDD
Mission Ultra Cholesterol Control Solution
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD for self-testing
CE/IVDD
Glucose Control Solutions
Bioland Technology Ltd.
·
,
China
Class C
CE/IVDR
V74 051313 0032
Active
Valid to Apr 2030
GUDID
on market
ELEMENT Blood Glucose Control Solution (Low)
OSANG HEALTHCARE Co., Ltd.
·
,
South Korea
IVD Annex II List B
CE/IVDD
careSTART™ Hb Biosensor Control
Wells Bio, Inc.
·
,
South Korea
IVD General
CE/IVDD
GLUCOFIX TECH Control
A. MENARINI Diagnostics S.r.l.
·
,
Italy
IVD Annex II List B
CE/IVDD
Lipid Control Solution
Changsha Sinocare Inc.
·
,
China
IVD General
CE/IVDD
Spengler TB100
Tyson Bioresearch, Inc.
·
,
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
Płyn kontrolny do pomiaru stężenia glukozy we krwi VivaChek Fad
Vivachek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
GLUCOCARD S Control Solution
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
On Call Plus Glucose Control Solution
Acon Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD Annex II List B
CE/IVDD
GLUCOCARD S Control Solution
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
GLUCOFIX TECH B-Ketone Control
A. MENARINI Diagnostics S.r.l.
·
,
Italy
IVD for self-testing
CE/IVDD
GLUCOCARD W Control Solution
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
GLUCOCARD S Control Solution
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
GLUCOCARD W Control Solution
ARKRAY Factory, Inc.
·
,
Japan
IVD Annex II List B
CE/IVDD
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