Biotinidase Quantitative Enzyme Assay Kit - Vietnam Registration 240001391/PCBB-HCM
Access comprehensive regulatory information for Biotinidase Quantitative Enzyme Assay Kit 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 240001391/PCBB-HCM and manufactured by Zentech SA. The authorized representative in Vietnam is CÔNG TY TNHH GAM MA VIỆT BỈ.
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Device Details
Registration Details
240001391/PCBB-HCM
000.00.19.H29-240605-0012
Theo theo phụ lục
Theo phụ lục
Technical Details
The quantitative enzymatic activity of biotinidase (BTD) is determined in dried blood samples from newborns on the 903 or 226 filter paper. Medical specialists use the test to screen for biotinidase deficiency. The test is performed on a semi-automatic or fully automatic system.
Dates and Status
Jul 08, 2024