Vietnam MOH registration 240000621/PCBB-HN

IVD Department quantitative testing of low-form factor (RF)

VN: Bộ IVD xét nghiệm định lượng yếu tố dạng thấp (RF)

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Chema Diagnostica Srl·Registered Mar 25, 2024

Registration details

Analysis ID: 240000621/PCBB-HN
Submission ID: 000.00.19.H26-240315-0011
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Chema Diagnostica Srl
Manufacturer Country: Theo theo phụ lục
Product Owner: Chema Diagnostica Srl
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ TRÍ ĐỨC

Technical details

Intended Use: RHEUMATOID FACTOR FL: A test to determine the concentration in vitro of the low molecular weight form of the factor in the biological fluid (serum) and aimed at supporting the diagnosis and prognosis of rheumatoid arthritis and other autoimmune diseases. The IVD device can be used on both manual and automated analyzers. The product is designed to be used professionally in clinical laboratories. RHEUMATOID FACTOR CONTROL SET: RF CONTROL SET is a liquid solution used to control the quality of the method for determining the low molecular weight form of the factor (RF). The solution is used to monitor the accuracy and/or precision on both automated and manual methods.

Dates and status

Registration Date: Mar 25, 2024

About this record

Access comprehensive regulatory information for IVD Department quantitative testing of low-form factor (RF) 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 240000621/PCBB-HN and manufactured by Chema Diagnostica Srl. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI DỊCH VỤ TRÍ ĐỨC.

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