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Immunochemistry (immunology)
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Standards and calibrators immunochemistry
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Specific protein standards and calibrators
Specific protein standards and calibrators
W0102152203
169 devices
SYNCHRON Systems PAB Calibrator
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
CLIA P-TAU-181 Calibrator
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Multiple Calibrator
Goldsite Diagnostics Inc.
·
,
China
IVD General
CE/IVDD
A1 Microglobulin Calibrator
Medicon Hellas SA
·
,
Greece
Class B
CE/IVDR
Ige Calibrator
Medicon Hellas SA
·
,
Greece
Class C
CE/IVDR
C-Reactive Protein (CRP) Calibrator
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
Malb/Uprot Control
Medicon Hellas SA
·
,
Greece
Class B
CE/IVDR
Saa Calibrator
Medicon Hellas SA
·
,
Greece
Class B
CE/IVDR
Homocysteine Standards
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
β-CTx Calibrators
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Access CEA Calibrators
Beckman Coulter, Inc.
·
,
United States
IVD General
FDA 510(k)
K223921
Active
Cleared 22 Sep 2023
CE/IVDD
+1
authorizations
Μalbumin Ip Calibrator Set
Vitalscientific
·
,
France
Class B
CE/IVDR
Fecal Occult Blood (Fob) Standard
Biosystems S.A.
·
,
Spain
IVD General
CE/IVDD
OC-FCa Calibrator
Eiken Chemical Co., Ltd.
·
,
Japan
Class B
CE/IVDR
CLIA Aβ1-42 Calibrator
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
IDS Calprotectin Calibrator Set
Immunodiagnostic Systems Limited
·
,
United Kingdom
Class B
CE/IVDR
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