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In vitro diagnostic medical devices
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Clinical chemistry
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Specific controls (clinical chemistry)
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Diabetes controls
Diabetes controls
W0101050205
87 devices
HbA1c Calibrator
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Blood Glucose Control Solutions
YASEE BioMedical Inc.
·
,
China
IVD Annex II List B
CE/IVDD
HbA1c Control High Level
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
CORMAY HbA1c DIRECT CONTROLS
PZ CORMAY Spółka Akcyjna
·
,
Poland
IVD General
CE/IVDD
OneTouch Verio Control Solution
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
Blood Glucose Control Solutions
Eaglenos Sciences, Inc.
·
,
China
IVD General
CE/IVDD
Glycosylated Hemoglobin A1c (HbA1c) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
ß-Ketone Control Solution L1
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
OneTouch Select Plus Control Solution
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
Blood Glucose Control Solution, Normal
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
extendSURE™ HbA1c Liquid Controls
Canterbury Scientific, Ltd.
·
,
New Zealand
IVD General
CE/IVDD
GUDID
on market
OneTouch Select Plus Control Solution
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
ß-Ketone Control Solution L2
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
HbA1c Control
Cypress Diagnostics
·
,
Belgium
IVD General
CE/IVDD
CERA-CHEK™ 1070 Glucose Control Solution
GC MEDIS Corp.
·
,
South Korea
IVD Annex II List B
CE/IVDD
Glycosylated Hemoglobin A1c (HbA1c) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
extendSURETM Haemoglobin A1c Lyophilised Controls
Canterbury Scientific, Ltd.
·
,
New Zealand
IVD General
CE/IVDD
GUDID
on market
OneTouch Select Plus Control Solution
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
HbA1c Control P
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Agamatrix Control Solution Normal
Agamatrix, Inc.
·
,
United States
IVD Annex II List B
CE/IVDD
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