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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
Cystatin C (Cys C) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Cystatin C Control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
α1-Microglobulin (α1-MG) Control
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
GlucoTrol-NG Level 2
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
Vitamin D Control – Rapi-D™ Quantitative Vitamin D Test
Affimedix, Inc.
·
,
United States
IVD General
CE/IVDD
C-reactive Protein (CRP) Control
Shenzhen Reetoo Biotechnology Co., Ltd
·
,
China
IVD General
CE/IVDD
ASO/CRP/RF Control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
Seronorm® Trace Elements Serum L-2
Sero As
·
,
Norway
IVD General
CE/IVDD
Vitamin D Control – CrinoCheck® Vitamin D
Affimedix, Inc.
·
,
United States
IVD General
CE/IVDD
Adams A1C Control
ARKRAY Factory, Inc.
·
,
Japan
IVD General
CE/IVDD
Assayed Multiple Chemistry Control (Multi-QC)
Maccura Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multichem MS VItD
Techno-Path Manufacturing
·
,
Ireland
Class B
CE/IVDR
GUDID
on market
Fibrinogen‐ONE Control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
Homocysteine quality control material
URIT Medical Electronic Co., Ltd.
·
,
China
IVD General
CE/IVDD
C‐Reactive Protein HS control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
Italy
IVD General
CE/IVDD
4SURE Level 1 KETONE CONTROL SOLUTION
ForaCare Suisse AG
·
,
Switzerland
IVD for self-testing
CE/IVDD
5'- Nucleotidase (5'-NT) quality control products
URIT Medical Electronic Co., Ltd.
·
,
China
IVD General
CE/IVDD
β-Ketone Control Solutions
Eaglenos Sciences, Inc.
·
,
China
IVD General
CE/IVDD
CERA-CHEK™ 3 in 1 GHL Lactate Control Solution
GC MEDIS Corp.
·
,
South Korea
IVD Annex II List B
CE/IVDD
GlucoTrol-NG Level 4
Eurotrol B.V.
·
,
Netherlands
IVD General
CE/IVDD
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