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DEVICE DETAILS

NAME OF DEVICESAMSUNG LABGEO HC10 HEMATOLOGY ANALYZER
ESTABLISHMENT NAMESILVER STATE LABORATORY SDN BHD
REGISTRATION NOIVDB10668419-35165
BRAND NAMESAMSUNG
DEVICE GROUPING TYPESYSTEM
DEVICE DESCRIPTIONThe Samsung LABGEO HC10 Hematology Analyzer measures impedance by using the Coulter Principle for counting cells passing through an aperture and optically measures the haemoglobin content of red blood cells. The analyzer features a graphical color LCD module with a touch screen and a START button. The software interfaces with a 58 mm built-in thermal printer module and allows sending results to an external printer via a USB port.
DEVICE INTENDED PURPOSEThe Samsung LABGEO HC10 is a quantitative, automated haematology analyzer and leukocyte differential counter for in vitro diagnostic use of whole blood specimens, developed for clinical laboratories.
VALIDITY DATE OF REGISTRATION04/10/2019 - 03/10/2024

LIST OF DEVICE

NONAME OF DEVICEIDENTIFIER
1Samsung LABGEO HC10IVR-C10A
2Samsung LABGEO HC DiluentIVR-C01A
3Samsung LABGEO HC LyseIVR-C03A
4Samsung LABGEO HC CleanerIVR-C04A
5Samsung LABGEO HC HypoCleanerIVR-C05A
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