Vietnam MOH registration 2400624ĐKLH/BYT-HTTB

Qualitative DNA Test Kit for Chlamydophila pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, Bordetella pertussis, Bordetella parapertussis, Streptococcus pneumoniae and Haemophilus influenzae

VN: Bộ xét nghiệm định tính ADN Chlamydophila pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, Bordetella pertussis, Bordetella parapertussis, Streptococcus pneumoniae và Haemophilus influenzae
Vietnam flagVietnam·Risk Class TTBYT Loại C·Allplex™ Respiratory Panel 4·Seegene, Inc.·Registered May 10, 2024
Registration details
Analysis ID
2400624ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-211214-0027
Product Type
Allplex™ Respiratory Panel 4
Product Code
RP9803Y
Company information
Manufacturer
Seegene, Inc.
Manufacturer Country
REPUBLIC OF
Technical details
Intended Use
Qualitative in vitro testing to detect single or multiple pathogens Chlamydophila pneumoniae (CP), Mycoplasma pneumoniae (MP), Legionella pneumophila (LP), Bordetella pertussis (BP), Bordetella parapertussis (BPP), Streptococcus pneumoniae (SP) and Haemophilus influenzae (HI) from the nasopharyngeal aspirate, nasopharyngeal swab, bronchoalveolar lavage and sputum samples.
Dates and status
Registration Date
May 10, 2024
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About this record

Access comprehensive regulatory information for Qualitative DNA Test Kit for Chlamydophila pneumoniae, Mycoplasma pneumoniae, Legionella pneumophila, Bordetella pertussis, Bordetella parapertussis, Streptococcus pneumoniae and Haemophilus influenzae 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 2400624ĐKLH/BYT-HTTB and manufactured by Seegene, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Seegene, Inc., and 2 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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