Qualitative Assay Kit for Influenza A, Influenza B, RSV A, RSV B and Influenza A - H1, - H3, and - H1pdm09 - Vietnam Registration 2400197ĐKLH/BYT-HTTB
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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Device Details
Registration Details
2400197ĐKLH/BYT-HTTB
000.00.04.G18-211214-0022
Allplex™ Respiratory Panel 1
RP9801Y
Technical Details
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
Feb 04, 2024

