Vietnam MOH registration 240000038/PCBB-HCM
IVD Fungal Infection - Immune
VN: Cụm IVD nhiễm nấm - Miễn dịch
theo phụ lục
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Dynamiker Biotechnology (Tianjin) Co., Ltd.·Registered Jan 03, 2024Registration details
- Analysis ID
- 240000038/PCBB-HCM
- Submission ID
- 000.00.19.H29-231226-0009
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Dynamiker Biotechnology (Tianjin) Co., Ltd.
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ KHOA HỌC KỸ THUẬT QUANG PHÁT
Technical details
- Intended Use
- - The Dynamiker Aspergillus Galactomannan Assay, based on the enzyme-linked immunosorbent assay (ELISA) competition test, is used to quantitatively detect Aspergillus glactomannan in human serum and bronchoalveolar lavage fluid (BAL) and is designated as a reference diagnostic test for Aspergillus infection. - The Dynamiker Candida Mannan, based on the enzyme-linked immunosorbent assay (ELISA) competition test, is used to quantitatively detect Candida mannan in human serum and is designated as a diagnostic test for Candida infection. - The Dynamiker Aspergillus fumigatus IgG, based on the enzyme-linked immunosorbent assay (ELISA) indirect test, is used to quantitatively detect IgG antibodies against the galactomannan of Aspergillus fumigatus in human serum or plasma and provides a diagnostic reference for Aspergillus fumigatus infection. - The Fungus (1-3)-β-D-Glucan Assay, based on the quantitative spectroscopy, is used to detect (1-3)-β-D-Glucan in human serum. It provides a diagnostic test for fungal infections.
Dates and status
- Registration Date
- Jan 03, 2024
About this record
Access comprehensive regulatory information for IVD Fungal Infection - Immune 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 240000038/PCBB-HCM and manufactured by Dynamiker Biotechnology (Tianjin) Co., Ltd.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KHOA HỌC KỸ THUẬT QUANG PHÁT.
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