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Qualitative Hemoglobin F, A, S, C Control Testing Material - Vietnam Registration 240002501/PCBB-HN

Access comprehensive regulatory information for Qualitative Hemoglobin F, A, S, C Control Testing Material in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002501/PCBB-HN and manufactured by Wallac Oy. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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240002501/PCBB-HN
Registration Details
Vietnam MOH Registration: 240002501/PCBB-HN
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Device Details

Qualitative Hemoglobin F, A, S, C Control Testing Material
VN: Vật liệu kiểm soát xét nghiệm định tính biến thể hemoglobin F, A, S, C
Risk Class TBYT Loại B

Registration Details

240002501/PCBB-HN

000.00.19.H26-240913-0011

RESOLVE Hb FASC Control kit

3412-0010

Company Information

Technical Details

The use of the material as a concentration-dependent dielectric control. The relative positions of the variants of hemoglobin A, F, S and C in the control material are used to monitor the performance of the hemoglobin test within the acceptable range when testing normal hemoglobin and variants in human blood samples.

Dates and Status

Sep 23, 2024