Vietnam MOH registration 230003072/PCBB-HN

IVD Department Quantitative CRP Testing

VN: Bộ IVD xét nghiệm định lượng CRP
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Theo theo phụ lục·Registered Nov 21, 2023
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
Company information
Manufacturer Country
Theo 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.
Dates and status
Registration Date
Nov 21, 2023
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About this record

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.

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