Vietnam MOH registration 2400165ĐKLH/BYT-HTTB

AHG Qualitative Test Card

VN: Thẻ xét nghiệm định tính AHG

Vietnam·Risk Class TTBYT Loại D·Anti-Human Globulin Anti-IgG, -C3d; polyspecific (Rabbit and Murine Monoclonal) (Green) Ortho BioVue® System (Poly Cassette)·Ortho-Clinical Diagnostics·Registered Feb 04, 2024

Registration details

Analysis ID: 2400165ĐKLH/BYT-HTTB
Submission ID: 19009434/ĐKLH-BYT-TB-CT
Product Type: Anti-Human Globulin Anti-IgG, -C3d; polyspecific (Rabbit and Murine Monoclonal) (Green) Ortho BioVue® System (Poly Cassette)
Product Code: 707350

Company information

Manufacturer: Ortho-Clinical Diagnostics
Manufacturer Country: UNITED KINGDOM
Product Owner: Ortho-Clinical Diagnostics
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM

Technical details

Intended Use: To detect the qualitative IgG/Complement binding to red blood cells on the Ortho BioVue system.

Dates and status

Registration Date: Feb 04, 2024

About this record

Access comprehensive regulatory information for AHG Qualitative Test Card in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2400165ĐKLH/BYT-HTTB and manufactured by Ortho-Clinical Diagnostics. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ SISC VIỆT NAM.

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