The IVD Marker for Rheumatoid Arthritis - Vietnam Registration 230000307/PCBB-HCM
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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Device Details
Registration Details
230000307/PCBB-HCM
000.00.19.H29-230201-0025
Theo theo phụ lục
Theo phụ lục
Technical Details
- 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 – 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
Feb 13, 2023