Quantitative testing of HbA, HbA2, HbF, qualitative and semi-quantitative testing of HbS, HbC, HbD, HbE - Vietnam Registration 220002948/PCBB-BYT
Access comprehensive regulatory information for Quantitative testing of HbA, HbA2, HbF, qualitative and semi-quantitative testing of HbS, HbC, HbD, HbE 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 220002948/PCBB-BYT and manufactured by Trinity Biotech.
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Device Details
Registration Details
220002948/PCBB-BYT
000.00.04.G18-220907-0007
Premier RESOLUTION MOBILE PHASE 1 REAGENT
01-03-0082
Technical Details
Trinity Biotech's Premier Resolution Mobile Phase 1 Reagent is used in conjunction with the Premier Resolution instrument. The product is not intended for use, distribution, registration, authorization, or licensing for any purpose other than as recommended by the manufacturer. The Trinity Biotech Premier Resolution Analyser is a high-performance liquid chromatography (HPLC) system designed to analyze various types of hemoglobin in blood samples from adult humans, adolescents, children, and infants, with the aim of: Quantifying normal hemoglobin types (A, A2, and F); Qualitatively by Quick Scan (QC) and semi-quantitatively by High Resolution (HR) determining the main variants of hemoglobin such as S, C, D-Los Angeles, and E. The test is performed on blood samples that are anticoagulated with K2EDTA, K3EDTA, sodium heparin, or lithium heparin. The Trinity Biotech Premier Resolution Analyser is intended for use only in specialized laboratories and must be used in conjunction with the reagents and analytical components supplied by Trinity Biotech. It is intended for in vitro diagnostic use.
Dates and Status
Sep 07, 2022

