Nucleic Acid Extraction Kit
Vietnam·Risk Class TTBYT Loại A·ExiPrep™ 48 Genomic DNA Kit·Bioneer Corporation·Registered Jul 02, 2024- Analysis ID
- 240001294/PCBA-HN
- Submission ID
- 000.00.19.H26-240625-0004
- Product Type
- ExiPrep™ 48 Genomic DNA Kit
- Product Code
- K-4574
- Manufacturer
- Bioneer Corporation
- Manufacturer Country
- REPUBLIC OF
- Product Owner
- Bioneer Corporation
- Authorized Representative
- CÔNG TY CỔ PHẦN Y TẾ ĐỨC MINH
- Intended Use
- ExiPrep™ 48 Genomic DNA Kit is an in vitro diagnostic test kit designed to extract genomic DNA from various clinical samples through the nucleic acid extraction device, ExiPrep™ 48 Dx (A-5150), and ExiStation™ 48 (A-2400). The genomic DNA is extracted from the clinical samples using a lysis buffer to disrupt the genomic structure. The exposed genomic DNA binds to the surface of the anionic silica particles in the binding buffer. The binding buffer washes away the residual contaminants in the sample, and the elution buffer washes out the pure genomic DNA from the silica particles. This kit is a nucleic acid extraction kit intended for professional use only.
- Registration Date
- Jul 02, 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 240001294/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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