Vietnam MOH registration 2400850ĐKLH/BYT-HTTB

Neisseria and Haemophilus Identification Test Card

VN: Thẻ xét nghiệm định danh vi khuẩn Neisseria, Haemophilus

Vietnam·Risk Class TTBYT Loại C·VITEK® 2 NH·bioMérieux, Inc.·Registered Jun 24, 2024

Registration details

Analysis ID: 2400850ĐKLH/BYT-HTTB
Submission ID: 17004301/ĐKLH-BYT-TB-CT
Product Type: VITEK® 2 NH
Product Code: 21346

Company information

Manufacturer: bioMérieux, Inc.
Manufacturer Country: UNITED STATES
Product Owner: bioMérieux, Inc.
Authorized Representative: CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM

Technical details

Intended Use: This manual corresponds to the VITEK® 2 Systems software version 7.01 or higher. If you are not using the VITEK® 2 Systems software version 7.01 or higher, please refer to the VITEK® 2 Systems product information (VITEK® 2 Systems Product Information) you received with your current software version. The Neisseria-Haemophilus VITEK® 2 (NH) ID card is used with the VITEK® 2 Systems to automatically identify most clinically significant fastidious microorganisms. The VITEK® 2 NH ID card is a single-use card. For a list of the species identified by the card, see the Microorganism Identification section.

Dates and status

Registration Date: Jun 24, 2024

About this record

Access comprehensive regulatory information for Neisseria and Haemophilus Identification Test Card 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 2400850ĐKLH/BYT-HTTB and manufactured by bioMérieux, Inc.. The authorized representative in Vietnam is CÔNG TY TNHH BIOMÉRIEUX VIỆT NAM.

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