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In vitro diagnostic medical devices
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Reagents
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Clinical chemistry
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Electrolytes reagents (excluding electrodes)
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Electrolytes - other
Electrolytes - other
W01010399
65 devices
SYNCHRON Systems ISE Electrolyte Reference Reagent
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
Ise Buffer
Beckman Coulter Ireland Inc.
·
,
Ireland
Class B
CE/IVDR
ISE Reference Solution
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
ISE Diluent
Dirui Industrial Co., Ltd
·
,
China
Class A
CE/IVDR
Diestro
JS Medicina Electrónica SRL
·
,
Argentina
Class A
CE/IVDR
Carbon Dioxide (CO2) Test Kit (Enzymatic)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
Blue & White
JS Medicina Electrónica SRL
·
,
Argentina
Class A
CE/IVDR
Carbon Dioxide (CO2) Test Kit (Enzymatic)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
ISE standard solution
Dirui Industrial Co., Ltd
·
,
China
IVD General
CE/IVDD
Carbohydrate Antigen 19-9 FIA
Assure Tech. (Hangzhou) Co., Ltd.
·
,
FDA registration: China
IVD General
CE/IVDD
ISE Low/High Urine Standard
Beckman Coulter Ireland Inc.
·
,
Ireland
Class B
CE/IVDR
Cartridge Chemistry Wash Solution (CCWA 2 x 300)
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
GUDID
on market
ISE High Serum Standard
Beckman Coulter Ireland Inc.
·
,
Ireland
Class B
CE/IVDR
MR Buffer Solution、MR Detergent Solution、MR Na/K Check Solution
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class A
CE/IVDR
Carbon Dioxide (CO2) Test Kit (Enzymatic)
Biobase Biodustry(Shandong) Co., Ltd.
·
,
China
IVD General
CE/IVDD
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