Quantitative testing of HbA, HbA2, HbF, qualitative and semi-quantitative testing of HbS, HbC, HbD, HbE
Vietnam·Risk Class TTBYT Loại B·Premier RESOLUTION MOBILE PHASE 2 REAGENT·Trinity Biotech·Registered Sep 07, 2022- Analysis ID
- 220002949/PCBB-BYT
- Submission ID
- 000.00.04.G18-220907-0010
- Product Type
- Premier RESOLUTION MOBILE PHASE 2 REAGENT
- Product Code
- 01-03-0083
- Manufacturer
- Trinity Biotech
- Manufacturer Country
- USA
- Intended Use
- Trinity Biotech's Premier Resolution Mobile Phase 2 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.
- Registration Date
- Sep 07, 2022
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