Vietnam MOH registration 240002501/PCBB-HN

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

Vietnam·Risk Class TBYT Loại B·RESOLVE Hb FASC Control kit·Wallac Oy·Registered Sep 23, 2024

Registration details

Analysis ID: 240002501/PCBB-HN
Submission ID: 000.00.19.H26-240913-0011
Product Type: RESOLVE Hb FASC Control kit
Product Code: 3412-0010

Company information

Manufacturer: Wallac Oy
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: 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

Registration Date: Sep 23, 2024

About this record

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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