The IVD (In Vitro Diagnostic) reference equipment cluster and control material of Biorex Diagnostics Ltd - Vietnam Registration 240000170/PCBB-HN
Access comprehensive regulatory information for The IVD (In Vitro Diagnostic) reference equipment cluster and control material of Biorex Diagnostics Ltd in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000170/PCBB-HN and manufactured by Biorex Diagnostics Ltd. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN SƠN MÀI VIỆT.
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Device Details
Registration Details
240000170/PCBB-HN
000.00.19.H26-240117-0020
Theo theo phụ lục
Theo phụ lục
Technical Details
- The HbA1c Calibrator Series is designed to calibrate quantitative HbA1c tests; - The HbA1c Control Set is designed to assess the accuracy and precision of the HbA1c analyte; - Calibration Serum is a calibrator serum used to calibrate clinical chemistry tests on multiple types of automated analyzers; - Human Assayed Control is a dried human serum control material with two levels (normal and high) used in the laboratory. It will be used to monitor the accuracy of the Calibration, Electrolyte, and Enzyme processes.
Dates and Status
Jan 23, 2024