Eu Ivdr Eu Ivd Class A Not Intended For Eu Market 🇨🇳 China

RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER

Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0

Basic Information

Primary DI
06954417600053
Basic UDI-DI Code
695441760901PT5X
Reference
NA
Device Types
New device
Regulation
Eu Ivdr
Classification
Eu Ivd Class A
Status
Not Intended For Eu Market

Additional Description

MQ-2000 PT Glycated Hemoglobin Analyzer can be used to monitor the HbA1c level in the whole blood sample of diabetic patients,and used for auxiliary diagnosis. PT is based on HPLC. It can separate HbA1ab、HbF, L-A1c, s-A1c and HbA0 in the hemoglobin component. The separated components then pass through a detector of UV-light at 415nm wavelength to test the absorbency, and the corresponding hemoglobin chromatogram is obtained. The result can be analyzed, recorded and stored by an embedded computing module and printed by a thermal printer.This instrument is composed of microcontroller unit, RF module, thermal printer, microinfusion pump, touch screen, automatic sample feeding mechanism, automatic sample injection mechanism, chromatographic column, inspection compartment, heating module,etc.

CND Nomenclature Codes

Code Description
W02020699 RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER

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