Vietnam MOH registration 240001880/PCBB-HN

Thyroid Function: anti-TG, anti-TPO

VN: Cụm chức năng tuyến giáp: anti-TG, anti-TPO

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Autobio Diagnostics Co., Ltd.·Registered Jul 30, 2024

Registration details

Analysis ID: 240001880/PCBB-HN
Submission ID: 000.00.19.H26-240720-0005
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer Country: Theo theo phụ lục
Product Owner: Autobio Diagnostics Co., Ltd.
Authorized Representative: CÔNG TY TNHH Y TẾ MINH NHẬT

Technical details

Intended Use: The test is based on the CLIA Microparticles chemiluminescent immunoassay to determine the concentration of anti-TG (antibodies against thyroglobulin) in human serum. The test is based on the CLIA Microparticles chemiluminescent immunoassay to determine the concentration of anti-TPO (antibodies against thyroid peroxidase) in human serum.

Dates and status

Registration Date: Jul 30, 2024

About this record

Access comprehensive regulatory information for Thyroid Function: anti-TG, anti-TPO 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 240001880/PCBB-HN and manufactured by Autobio Diagnostics Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH Y TẾ MINH NHẬT.

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