Vietnam MOH registration 230000307/PCBB-HCM

The IVD Marker for Rheumatoid Arthritis

VN: Cụm IVD các dấu hiệu bệnh viêm khớp

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Feb 13, 2023

Registration details

Analysis ID: 230000307/PCBB-HCM
Submission ID: 000.00.19.H29-230201-0025
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Theo theo phụ lục
Manufacturer Country: Theo theo phụ lục

Technical details

Intended Use: - ASO Latex Test Kit is a precipitation test on a slide for qualitative and semiquantitative detection of anti-streptolysin O (ASO) in human serum. The latex particles are coated with streptolysin O (SLO) and precipitate when mixed with samples containing ASO. - C-Reactive Protein (CRP) Latex Test Kit is a precipitation test on a slide for qualitative and semiquantitative detection of C-reactive protein (CRP) in human serum. The latex particles are coated with anti-human CRP IgG antibody and precipitate when mixed with samples containing CRP. - Rheumatoid Factor &#x2013; RA (RF) Latex Test Kit is a precipitation test on a slide for qualitative detection and semiquantitative determination of rheumatoid factor in human serum. The latex particles are coated with human gamma globulin and precipitate when mixed with samples containing rheumatoid factor.

Dates and status

Registration Date: Feb 13, 2023

About this record

Access comprehensive regulatory information for The IVD Marker for Rheumatoid Arthritis 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 230000307/PCBB-HCM and manufactured by Theo theo phụ lục.

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