Linearization Control Material on the Test Strips and Glucose Meter - Vietnam Registration 2400650ĐKLH/BYT-HTTB
Access comprehensive regulatory information for Linearization Control Material on the Test Strips and Glucose Meter in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2400650ĐKLH/BYT-HTTB and manufactured by Bionostics Inc. The authorized representative in Vietnam is CÔNG TY TNHH ROCHE VIỆT NAM.
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Device Details
Registration Details
2400650ĐKLH/BYT-HTTB
18007670/ĐKLH-BYT-TB-CT
ACCU-CHEK® Linearity Test Kit
05048010001
Technical Details
The linear solution is used to test the linearity on the test strips and the dedicated blood glucose meter. It is intended for use by healthcare professionals to perform in-clinic tests on patients. It should only be used to test the linearity of the Accu‑Chek meters that use the Accu‑Chek Aviva, Accu‑Chek Performa, and Accu‑Chek Inform II test strips.
Dates and Status
May 10, 2024