IVD Department Quantitative CRP Testing - Vietnam Registration 230003072/PCBB-HN

Access comprehensive regulatory information for IVD Department Quantitative CRP Testing 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 230003072/PCBB-HN and manufactured by Theo theo phụ lục.

This page provides complete technical specifications, regulatory compliance details, 5 companies making similar products including Meril Diagnostics Pvt. Ltd, Shenzhen Dymind Biotechnology Co., Ltd., 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

230003072/PCBB-HN

Registration Details

Vietnam MOH Registration: 230003072/PCBB-HN

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing

Device Details

IVD Department Quantitative CRP Testing

VN: Bộ IVD xét nghiệm định lượng CRP

Risk Class TTBYT Loại B

Registration Details

Analysis ID

230003072/PCBB-HN

Submission ID

000.00.19.H26-231114-0043

Product Type

Theo theo phụ lục

Product Code

Theo phụ lục

Technical Details

Intended Use

- CRP Quantitative Test Kit: The test kit used in in vitro diagnosis to allow trained laboratory specialists to perform automated quantitative measurement of the concentration of C-reactive protein in serum and plasma samples. The product is packaged for use with the Beckman Coulter AU biochemical flow analyzer. -Chemical Standard for Quantitative CRP Testing: The chemical standard used to establish reference curves for the quantitative determination of C-Reactive Protein with the Medicon test. For in vitro diagnosis, to be performed by trained laboratory specialists only.