IVD Cluster Autoimmune Diseases
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Monobind, Inc.·Registered Aug 09, 2024- Analysis ID
- 240001752/PCBB-HCM
- Submission ID
- 000.00.19.H29-240802-0026
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Monobind, Inc.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Monobind, Inc.
- Authorized Representative
- CÔNG TY CỔ PHẦN Y TẾ FUSION
- Intended Use
- 1.Anti-Tg AccuBind ELISA Test System: The test system used to determine the quantitative amount of Thyroglobulin (Tg) autoantibodies in human serum or plasma by enzyme-linked immunosorbent assay (ELISA), measuring color. The measurement of Tg autoantibodies can support the diagnosis of certain thyroid disorders, such as Hashimoto's disease and Graves' disease, as well as non-toxic goiter. 2.Anti-TPO AccuBind ELISA Test System: The test system used to determine the quantitative amount of Thyroid Peroxidase (TPO) autoantibodies in human serum or plasma by enzyme-linked immunosorbent assay (ELISA), measuring color. The measurement of TPO autoantibodies can support the diagnosis of certain thyroid disorders, such as Hashimoto's disease and Graves' disease, as well as non-toxic goiter.
- Registration Date
- Aug 09, 2024
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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 240001752/PCBB-HCM and manufactured by Monobind, Inc.. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ FUSION.
This page provides complete technical specifications, regulatory compliance details, 2 companies making similar products including Theo theo phụ lục, DRG Instruments GmbH, 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.