Vietnam MOH registration 2301695ĐKLH/BYT-HTTB

Qualitative DNA Test Kit for Neisseria meningitidis, Listeria monocytogenes, Haemophilus influenzae, Streptococcus agalactiae, Streptococcus pneumoniae, Escherichia coli K1

VN: Bộ xét nghiệm định tính ADN Neisseria meningitidis, Listeria monocytogenes, Haemophilus influenzae, Streptococcus agalactiae, Streptococcus pneumoniae, Escherichia coli K1

Vietnam·Risk Class TTBYT Loại C·Allplex™ Meningitis-B Assay·Seegene, Inc.·Registered Dec 22, 2023

Registration details

Analysis ID: 2301695ĐKLH/BYT-HTTB
Submission ID: 20011331/ĐKLH-BYT-TB-CT
Product Type: Allplex™ Meningitis-B Assay
Product Code: MG9600X

Company information

Manufacturer: Seegene, Inc.
Manufacturer Country: REPUBLIC OF

Technical details

Intended Use: In vitro qualitative testing to detect either single or multiple pathogens Neisseria meningitidis (NM), Listeria monocytogenes (LM), Haemophilus influenzae (HI), Streptococcus agalactiae (GBS), Streptococcus pneumoniae (SP), and Escherichia coli K1 (ECK1) from cerebrospinal fluid samples

Dates and status

Registration Date: Dec 22, 2023

About this record

Access comprehensive regulatory information for Qualitative DNA Test Kit for Neisseria meningitidis, Listeria monocytogenes, Haemophilus influenzae, Streptococcus agalactiae, Streptococcus pneumoniae, Escherichia coli K1 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 2301695ĐKLH/BYT-HTTB and manufactured by Seegene, Inc..

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