Vietnam MOH registration 2400197ĐKLH/BYT-HTTB

Qualitative Assay Kit for Influenza A, Influenza B, RSV A, RSV B and Influenza A - H1, - H3, and - H1pdm09

VN: Bộ xét nghiệm định tính ARN virus cúm A, cúm B, RSV A, RSV B và chủng cúm A - H1,- H3, và - H1pdm09
Vietnam flagVietnam·Risk Class TTBYT Loại C·Allplex™ Respiratory Panel 1·Seegene, Inc.·Registered Feb 04, 2024
Registration details
Analysis ID
2400197ĐKLH/BYT-HTTB
Submission ID
000.00.04.G18-211214-0022
Product Type
Allplex™ Respiratory Panel 1
Product Code
RP9801Y
Company information
Manufacturer
Seegene, Inc.
Manufacturer Country
REPUBLIC OF
Technical details
Intended Use
Qualitative in vitro testing to detect single or multiple strains of Influenza A virus (Flu A), Influenza B virus (Flu B), Human respiratory syncytial virus A (RSV A), Human respiratory syncytial virus B (RSV B), Human Influenza A virus subtype H1 (Flu A-H1), Human Influenza A virus subtype H3 (Flu A-H3), and Human Influenza A virus subtype H1pdm09 (Flu A-H1pdm09) from the nasopharyngeal aspirate, nasopharyngeal swab, and bronchoalveolar lavage samples.
Dates and status
Registration Date
Feb 04, 2024
About this record

Access comprehensive regulatory information for Qualitative Assay Kit for Influenza A, Influenza B, RSV A, RSV B and Influenza A - H1, - H3, and - H1pdm09 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 2400197ĐKLH/BYT-HTTB and manufactured by Seegene, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ Y TẾ PHƯƠNG ĐÔNG.

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