Vietnam MOH registration 240001669/PCBB-HN

IVD Inflammatory Joint Marker Cluster

VN: Cụm IVD dấu ấn viêm khớp
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·AMEDA Labordiagnostik GmbH·Registered Jul 11, 2024
Registration details
Analysis ID
240001669/PCBB-HN
Submission ID
000.00.19.H26-240708-0029
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Product Owner
AMEDA Labordiagnostik GmbH
Technical details
Intended Use
- AMP ASLO Latex: To determine the qualitative and semi-quantitative clinical significance of the antibody against streptolysin O (ASLO) in human serum. - AMP RF Latex & AMP RF Waaler: To determine the qualitative and semi-quantitative clinical significance of the rheumatoid factors (RF) in human serum. - AMP CRP Latex: To determine the qualitative and semi-quantitative clinical significance of the C-Reactive Protein (CRP) in human serum.
Dates and status
Registration Date
Jul 11, 2024
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About this record

Access comprehensive regulatory information for IVD Inflammatory Joint Marker Cluster 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 240001669/PCBB-HN and manufactured by AMEDA Labordiagnostik GmbH. The authorized representative in Vietnam is CÔNG TY TNHH PHÁT TRIỂN VÀ CHUYỂN GIAO CÔNG NGHỆ THỊNH PHÁT.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Theo theo phụ lục, and 1 recent registrations in the same category. Pure Global AI offers free access to 300,000+ Vietnamese medical device registrations, helping global MedTech companies navigate Vietnam MOH regulations, identify competitors, and discover partnership opportunities efficiently.

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