Vietnam MOH registration 240000683/PCBB-HCM

IVD Cluster Autoimmune Diseases

VN: Cụm IVD Các bệnh tự miễn dịch
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·DRG Instruments GmbH·Registered Apr 02, 2024
Registration details
Analysis ID
240000683/PCBB-HCM
Submission ID
000.00.19.H29-240325-0021
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer Country
Theo theo phụ lục
Product Owner
DRG Instruments GmbH
Technical details
Intended Use
1.c-ANCA (PR3) ELISA is a test to quantify the autoantibodies IgG against proteinase 3 (PR3) in human serum or plasma. 2.pANCA (MPO) ELISA is a test to quantify the autoantibodies IgG against myeloperoxidase (MPO) in human serum or plasma. 3.Anti-ASGPR IgG ELISA is an immuno-diffusion quantitative test to determine the antibodies IgG against the asialoglycoprotein receptor (ASGPR) in human serum. 4. Anti-C1q ELISA is a test to quantify the autoantibodies IgG against C1q in human serum or plasma.
Dates and status
Registration Date
Apr 02, 2024
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About this record

Access comprehensive regulatory information for IVD Cluster Autoimmune Diseases 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 240000683/PCBB-HCM and manufactured by DRG Instruments GmbH. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA.

This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Monobind, Inc., Theo theo phụ lục, and 2 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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