Nucleic Acid Extraction Kit - Vietnam Registration 240001294/PCBA-HN

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.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including QIAGEN GmbH, Zinexts Life Science Corp., and 5 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.

Free Database

300,000+ Devices

5 Competitors

5 Recent Registrations

240001294/PCBA-HN

Registration Details

Vietnam MOH Registration: 240001294/PCBA-HN

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

Nucleic Acid Extraction Kit

VN: Bộ kit tách chiết axit nucleic

Risk Class TTBYT Loại A

Registration Details

Analysis ID

240001294/PCBA-HN

Submission ID

000.00.19.H26-240625-0004

Product Type

ExiPrep™ 48 Genomic DNA Kit

Product Code

K-4574

Technical Details

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.