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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)
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Specific controls (cc) - other
Specific controls (cc) - other
W0101050299
153 devices
Devices
MAS ChemTrak H Liquid Assayed Chemistry Control
Microgenics Corporation
·
,
US
IVD General
CE/IVDD
GUDID
on market
β2-MG ClinChem Control
Autobio Biochemistry Co., Ltd
·
,
CN
Class B
CE/IVDR
Multiparametric Specific Proteins Control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
IT
IVD General
CE/IVDD
Specific Protein Control Serum
Dirui Industrial Co., Ltd
·
,
CN
IVD General
CE/IVDD
HbA1c Hemoglobin Control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
IT
IVD General
CE/IVDD
CERA-CHEK™ Lactate Control Solution
GC MEDIS Corp.
·
,
KR
IVD for self-testing
CE/IVDD
Cystatin C (Cys C) Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
α1-Microglobulin (α1-MG) Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/IVDD
Seronorm® Trace Elements Whole Blood L-2
Sero As
·
,
NO
IVD General
CE/IVDD
Optilite® Low Level Total Protein Controls
The Binding Site Group Ltd
·
,
GB
Class B
CE/IVDR
GUDID
on market
Lipoprotein A
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
IT
IVD General
CE/IVDD
Immunoglobulin E Control
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
IT
IVD General
CE/IVDD
Cystatin C (Cys C) Control
Maccura Biotechnology Co., Ltd.
·
,
CN
IVD General
CE/MDR
MassTrak™ Steroid Serum QC Set 2
Waters Corporation
·
,
US
Class B
CE/IVDR
GUDID
on market
OSMO STATION Control Solution Set
ARKRAY Factory, Inc.
·
,
JP
IVD General
CE/IVDD
Fructosamine Control Serum
Biosystems S.A.
·
,
ES
IVD General
CE/IVDD
Hct Control Level A
Eurotrol B.V.
·
,
NL
IVD General
CE/IVDD
GUDID
on market
One‐trol 3
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
IT
IVD General
CE/IVDD
Vitamin D Control – botiss CARE Rapi-D™ Quantitative Vitamin D Test
Affimedix, Inc.
·
,
US
IVD General
CE/IVDD
Control For Biogenic Amines In Urine - Levels 1 And 2
Eureka S.R.L. Lab Division
·
,
IT
IVD General
CE/IVDD
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