Total Bilirubin at the Bedside Measurement System - Vietnam Registration 240000645/PCBB-HCM
Access comprehensive regulatory information for Total Bilirubin at the Bedside Measurement System 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 240000645/PCBB-HCM and manufactured by Bilimetrix S.r.l.,. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ DMED.
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Device Details
Registration Details
240000645/PCBB-HCM
000.00.19.H29-240320-0008
Theo theo phụ lục
Theo phụ lục
Technical Details
Bilistick® is a point-of-care diagnostic instrument for the determination of total serum bilirubin (TSB) concentration in the blood of newborns. The determination of TSB concentration using the Bilistick® system does not require the use of reagents, thus simplifying the measurement process. After the sample is loaded, the concentration of bilirubin is calculated and displayed within a few minutes. The Bilistick® system allows for the determination of bilirubin concentration in the range from 1 mg/dL to 40 mg/dL (17 to 684 µmol/L) with accuracy comparable to that of traditional clinical laboratory instruments.
Dates and Status
Mar 27, 2024