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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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Calibrators and standards (clinical chemistry)
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Calibrators single component (cc)
Calibrators single component (cc)
W0101050302
109 devices
Devices
Hb A1c CAPILLARY CALIBRATORS (5x2)
Sebia
·
,
FR
Class C
CE/IVDR
HDL Cholesterol Calibrator
Beckman Coulter Ireland Inc.
·
,
IE
Class B
CE/IVDR
STANDARD™ F Calibration Kit
SD Biosensor Inc.
·
,
KR
Class A
CE/IVDR
Microalbumin Calibrator
C.P.M. Compagnia Per La Medicina S.R.L.
·
,
IT
IVD General
CE/IVDD
Hemoglobin A1c Calibrator Set
Tosoh Corporation
·
,
JP
Class C
CE/IVDD
CE/IVDR
+1
authorizations
Hb A1c CAPILLARY CALIBRATORS (2)
Sebia
·
,
FR
Class C
CE/IVDR
Pancreatic Amylase Calibrator
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class C
CE/IVDR
Ammonia Calibrator
Medicon Hellas SA
·
,
GR
IVD General
CE/IVDD
AutoChem β2-MG Calibrator
Autobio Biochemistry Co., Ltd
·
,
CN
Class B
CE/IVDR
Ada 2 Calibrator
Medicon Hellas SA
·
,
GR
Class C
CE/MDR
Optilite® Low Level Total Protein Calibrator
The Binding Site Group Ltd.
·
,
GB
Class B
CE/IVDR
GUDID
on market
SYNCHRON Systems MA Calibrator
Beckman Coulter, Inc.
·
,
US
IVD General
CE/IVDD
GUDID
on market
MCM Calibrator
Changchun Medicside Medical Technology Co., Ltd
·
,
CN
Class B
CE/IVDR
AutoChem β2-MG Calibrator
Autobio Biochemistry Co., Ltd
·
,
CN
Class B
CE/IVDR
ADA Calibrator
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
CN
Class B
CE/IVDR
KEYU Urine Analysis Specific Gravity Calibrator
Zhuhai Keyu Biological Engineering Co., Ltd
·
,
CN
IVD General
CE/IVDD
Aldolase Calibration Serum (Als Cal)
Randox Laboratories Limited
·
,
XI
Class B
FDA 510(k)
K142181
Active
Cleared 18 Sep 2014
CE/IVDR
+1
authorizations
Hdl Calibrator
Medicon Hellas SA
·
,
GR
Class B
CE/IVDR
ClinCal® Serum Calibrator Set lyophilised, for CDT
RECIPE Chemicals + Instruments GmbH
·
,
DE
Class B
CE/IVDR
CFΔ Collection System
Utsat Sağlik Teknoloji̇leri̇ Sanayi̇ Ti̇caret Li̇mi̇ted Şi̇rketi̇
·
,
TR
Class A
CE/IVDR
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