Nucleic Acid Extraction Kit
Vietnam·Risk Class TTBYT Loại A·ExiPrep™ Dx Viral DNA/RNA Kit·Bioneer Corporation·Registered May 23, 2024- Analysis ID
- 240000939/PCBA-HN
- Submission ID
- 000.00.19.H26-240408-0012
- Product Type
- ExiPrep™ Dx Viral DNA/RNA Kit
- Product Code
- K-4471
- Manufacturer
- Bioneer Corporation
- Manufacturer Country
- REPUBLIC OF
- Product Owner
- Bioneer Corporation
- Authorized Representative
- CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH
- Intended Use
- ExiPrep™ Dx Viral DNA/RNA Kit is an in vitro diagnostic kit designed to extract viral DNA or RNA from clinical specimen samples through the nucleic acid extraction device, specifically ExiPrep™ 16 Dx and ExiStation™ Universal Molecular Diagnostic System. The viral DNA/ARN is extracted from the clinical specimen samples by the lysis buffer solution, which disrupts the structure of the virus. The viral DNA/ARN is then adsorbed onto the surface of silica particles in the binding buffer solution. The binding buffer solution washes away the impurities, and the elution buffer solution releases the viral DNA/ARN from the silica particles. This kit is intended for professional use only for the extraction of nucleic acids.
- Registration Date
- May 23, 2024
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Access comprehensive regulatory information for Nucleic Acid Extraction Kit in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000939/PCBA-HN and manufactured by Bioneer Corporation. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH.
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