RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER

Primary DI

06954417600060

Basic UDI-DI Code

69544176120160XB

Reference

NA

Device Types

New device

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

Not Intended For Eu Market

Manufacturer

Shanghai Medconn Medical Technology Co.,Ltd.

The MQ-6000 analyzer uses HPLC to separate HbA1c from non-glycated hemoglobin according to the difference in their charges. The absorbance of the separated elution solutions is detected by an ultraviolet light at a wavelength of 415 nm to obtain the chromatograms of corresponding hemoglobins. The HbA1c value is expressed as a percentage of the area of HbA1c peak to the area of the entire hemoglobin in the chromatogram. The result is then displayed on the screen and printed using the printer. The MQ-6000 analyzer has high separation efficiency, good stability, low carry-over rate, fast sample analysis speed and strong anti-interference ability. It can effectively eliminate the interference of substances such as bilirubin, chyle, glucose, ascorbic acid and acetaldehyde. It can also effectively separate the variants of hemoglobin such as HbF and L-A1c, so as to reduce the interference of hemoglobin variants on the test results of glycated hemoglobin and to make the measurement results more accurate.The instrument is mainly composed of a micro control unit, an automatic sample loading mechanism, a high pressure pump, a detector, a column oven, a touch screen, a thermal printer, and an RF card module.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).