Vietnam MOH registration 2300565ĐKLH/BYT-HTTB

Qualitative test for Streptococcus pneumoniae antigen

VN: Thanh thử xét nghiệm định tính kháng nguyên Streptococcus pneumoniae

Vietnam·Risk Class TTBYT Loại C·BinaxNOW™ Streptococcus pneumonia Antigen Card·Abbott Diagnostics Scarborough, Inc.·Registered Jun 20, 2023

Registration details

Analysis ID: 2300565ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210820-0025
Product Type: BinaxNOW™ Streptococcus pneumonia Antigen Card
Product Code: 710-000

Company information

Manufacturer: Abbott Diagnostics Scarborough, Inc.
Manufacturer Country: UNITED STATES

Technical details

Intended Use: BinaxNOW™ Streptococcus pneumoniae Antigen Card (BinaxNOW Streptococcus pneumoniae) is an in vitro rapid immunochromatographic (ICT) test to detect the presence of Streptococcus pneumoniae antigen in the urine of patients with pneumonia and in the cerebrospinal fluid (CSF) of patients with meningitis. The product is intended to be used in conjunction with culture and other methods to aid in the diagnosis of both pneumococcal pneumonia and pneumococcal meningitis.

Dates and status

Registration Date: Jun 20, 2023

About this record

Access comprehensive regulatory information for Qualitative test for Streptococcus pneumoniae antigen in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2300565ĐKLH/BYT-HTTB and manufactured by Abbott Diagnostics Scarborough, Inc..

This page provides complete technical specifications, regulatory compliance details. 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.