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In vitro diagnostic medical devices
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Clinical chemistry
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Controls/standards/calibrators clinical chemistry
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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
VALIDATE® LP Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
VALIDATE® Whole Blood Glucose Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Lipid Control - Level 1 (Lpd Control 1)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Lipid Control Serum
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
HDL/LDL Control
Cypress Diagnostics
·
,
Belgium
IVD General
CE/IVDD
Vivadiag
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Lipid Control - Level 1 (Lpd Control 1)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
Lipidic Control Set
Futurlab S.R.L.
·
,
Italy
IVD General
CE/IVDD
Vivadiag
VivaChek Biotech (Hangzhou) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Specitrol
Thermo Fisher Scientific Oy
·
,
Finland
IVD General
CE/IVDR
CE/IVDD
MAS CardioImmune XL Liquid Assayed Cardiac Marker Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Specitrol High
Thermo Fisher Scientific Oy
·
,
Finland
IVD General
CE/IVDR
CE/IVDD
Lipid Control - Level 3 (Lpd Control 3)
Randox Laboratories Limited
·
,
Northern Ireland
Class B
CE/IVDR
GUDID
on market
VALIDATE® LP Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Lipotrol
Thermo Fisher Scientific Oy
·
,
Finland
Class B
CE/IVDR
VALIDATE® LP Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
MAS CardioImmune XL Liquid Assayed Cardiac Marker Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Low-Density Lipoprotein Cholesterol Control
Medicalsystem Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
VALIDATE® LP Test Set
LGC Clinical Diagnostics, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
MulticareIN Triglycerides Control Solution - ITA / ENG
Biochemical Systems International S.p.A.
·
,
Italy
IVD Annex II List B
CE/IVDD
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