Vietnam MOH registration 240002085/PCBB-HN
In vitro rapid diagnostic test kit for detecting antibodies against Aspergillus in human serum
VN: Bộ xét nghiệm chẩn đoán nhanh in vitro phát hiện kháng thể kháng Aspergillus trong huyết thanh người
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·LDBIO Diagnostics·Registered Aug 16, 2024Registration details
- Analysis ID
- 240002085/PCBB-HN
- Submission ID
- 000.00.19.H26-240815-0001
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- LDBIO Diagnostics
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- LDBIO Diagnostics
- Authorized Representative
- CÔNG TY TNHH THIẾT BỊ KHOA HỌC VIỆT ANH
Technical details
- Intended Use
- The rapid immunoassay based on the liquid chromatography technology allows the simultaneous detection of both IgG and IgM antibodies against Aspergillus in human serum.
Dates and status
- Registration Date
- Aug 16, 2024
About this record
Access comprehensive regulatory information for In vitro rapid diagnostic test kit for detecting antibodies against Aspergillus in human serum 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 240002085/PCBB-HN and manufactured by LDBIO Diagnostics. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KHOA HỌC VIỆT ANH.
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