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In vitro diagnostic medical devices
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Specific controls (clinical chemistry)
Specific controls (clinical chemistry)
W01010502
498 devices
Subcategories
8
W0101050201
Enzyme controls
53
devices
W0101050202
Lipid controls
39
devices
W0101050203
Bilirubin controls
22
devices
W0101050204
Electrolyte controls
42
devices
W0101050205
Diabetes controls
87
devices
W0101050207
Urine controls
96
devices
W0101050208
Csf controls
6
devices
W0101050299
Specific controls (cc) - other
153
devices
Devices
Blood Glucose Control Solution_Y1
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
MAS Diabetes Liquid Assayed Diabetes Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
OneTouch Ultra Plus Control Solution
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
GlucoLeader Enhance Glucose Control Solution
Hmd Biomedical Inc.
·
,
Taiwan
IVD Annex II List B
CE/IVDD
OneTouch Select Plus Control Solution
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
OneTouch Verio Control Solution
Lifescan Europe
·
,
Switzerland
IVD Annex II List B
CE/IVDD
CERA-STAT™ HbA1c Control Solution
GC MEDIS Corp.
·
,
South Korea
IVD General
CE/IVDD
Hemoglobin A1c Control Set
Tosoh Corporation
·
,
Japan
Class C
CE/IVDR
GUDID
on market
4SURE Level 2 Blood Glucose Control Solution
ForaCare Suisse AG
·
,
Switzerland
IVD Annex II List B
CE/IVDD
MAS Diabetes Liquid Assayed Diabetes Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
GLUCO TEST Plus Kontrolllösung hoch
Taidoc Technology Corporation
·
,
Taiwan
IVD Annex II List B
CE/IVDD
CERA-CHEK™ 3 in 1 GHL Glucose Control Solution
GC MEDIS Corp.
·
,
South Korea
IVD Annex II List B
CE/IVDD
Glycated Hemoglobin A1c Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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
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