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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
Specific Protein Control Serum
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
HbA1c Hemoglobin Control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
CERA-CHEK™ Lactate Control Solution
GC MEDIS Corp.
·
,
South Korea
IVD for self-testing
CE/IVDD
Cystatin C (Cys C) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
α1-Microglobulin (α1-MG) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Seronorm® Trace Elements Whole Blood L-2
Sero As
·
,
Norway
IVD General
CE/IVDD
Optilite® Low Level Total Protein Controls
The Binding Site Group Ltd
·
,
United Kingdom
Class B
CE/IVDR
GUDID
on market
Lipoprotein A
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
Immunoglobulin E Control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
Cystatin C (Cys C) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
MassTrak™ Steroid Serum QC Set 2
Waters Corporation
·
,
United States
Class B
CE/IVDR
GUDID
on market
OSMO STATION Control Solution Set
ARKRAY Factory, Inc.
·
,
Japan
IVD General
CE/IVDD
Fructosamine Control Serum
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
Hct Control Level A
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
GUDID
on market
One‐trol 3
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test
Affimedix, Inc.
·
,
United States
IVD General
CE/IVDD
Control For Biogenic Amines In Urine - Levels 1 And 2
Eureka S.R.L. Lab Division
·
,
Italy
IVD General
CE/IVDD
Total Bile Acids (TBA) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
MAS ChemTrak H Liquid Assayed Chemistry Control
Microgenics Corporation
·
,
United States
IVD General
CE/IVDD
GUDID
on market
β2-MG Clinchem Control
Autobio Biochemistry Co., Ltd
·
,
China
Class B
CE/IVDR
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