Nucleic Acid Extraction Kit - Vietnam Registration 240000939/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 240000939/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

240000939/PCBA-HN

Registration Details

Vietnam MOH Registration: 240000939/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

240000939/PCBA-HN

Submission ID

000.00.19.H26-240408-0012

Product Type

ExiPrep™ Dx Viral DNA/RNA Kit

Product Code

K-4471

Technical Details

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.