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In vitro diagnostic medical devices
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Immunochemistry (immunology)
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Immunochemistry controls/standards/calibrators
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Standards and calibrators immunochemistry
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Tumour marker standards and calibrators
Tumour marker standards and calibrators
W0102152205
77 devices
AutoLumo CA50 Calibrators
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
PGⅡ Calibrators
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class C
CE/IVDR
AutoLumo SCCA Calibrators
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
CLIA CEA Calibrator
Shenzhen Superbio Technology Co., Ltd.
·
,
China
IVD General
CE/IVDD
μTASWako AFP-L3 Calibrator Set
Fujifilm Wako Pure Chemical Corporation
·
,
Japan
Class C
CE/IVDR
GUDID
on market
AutoLumo CA19-9 Calibrators
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
B2M Calibrator
Medicon Hellas SA
·
,
Greece
IVD General
CE/IVDD
β2-Microglobulin Calibrator (for Urine)
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Access OV Monitor (Calibrators)
Beckman Coulter, Inc.
·
,
United States
Class C
FDA 510(k)
K240479
Active
Cleared 10 May 2024
CE/IVDR
+1
authorizations
AutoLumo HER-2/neu CLIA Microparticles
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
AutoLumo CA19-9 Calibrators
Autobio Diagnostics Co., Ltd.
·
,
China
Class C
CE/IVDR
Access AFP (Calibrators)
Beckman Coulter, Inc.
·
,
United States
Class C
CE/IVDR
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