RAPID TEST HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - OTHER

Primary DI

06954417600121

Basic UDI-DI Code

69544176150180YJ

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.

MQ-8000PT are used to detect the content of Glycated hemoglobin. Analyzer detects Glycated hemoglobin based on the principle of HPLC. The analyzer first equilibrates the chromatography column with an ultra-low concentration reagent, and then rinses the chromatography column with a low concentration reagent. The HbA1c of the sample adsorbed on the chromatography column polymer is first eluted. The non-HbA1c is then eluted with a high-concentration reagent. For each separated hemoglobin component, the detector continuously obtains the absorbance of each component by photoelectric colorimetry and generates a chromatographic curve. The micro-control unit performs peak identification and integral calculation of each peak area on the chromatographic curve, and calculates the percentage of the peak area of HbA1c to the total area. The value calibrated by the slope and intercept of the calibration curve serves as the HbA1c value of the sample.

The Basic UDI-DI associated with this device has 2 devices in total. Below are some other devices sharing the same Basic UDI-DI.

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