Vietnam MOH registration 240002488/PCBB-HCM

Screening and sensitivity test for antibiotics of gram-negative aerobic and anaerobic bacteria that are adaptable

VN: Thuốc thử xét nghiệm định danh và tính nhạy cảm với kháng sinh của vi khuẩn gram âm hiếu khí và kỵ khí tuỳ nghi
Vietnam flagVietnam·Risk Class TBYT Loại B·BD Phoenix™ NMIC/ID-504·Becton, Dickinson and Company (BD)·Registered Oct 30, 2024
Registration details
Analysis ID
240002488/PCBB-HCM
Submission ID
000.00.19.H29-241014-0014
Product Type
BD Phoenix™ NMIC/ID-504
Product Code
449027
Company information
Product Owner
Bd
Technical details
Intended Use
BD Phoenix™ NMIC/ID-504, a test for the rapid identification and antimicrobial susceptibility testing of gram-negative bacteria, is used to quickly identify and test the susceptibility of most gram-negative aerobic and anaerobic bacteria of human origin (for a complete list of microorganisms, refer to the BD Phoenix™ System User Guide). The BD Phoenix™ System, an automated microbial identification and susceptibility testing system, functions as a diagnostic tool, providing both qualitative and quantitative susceptibility test results, when used in conjunction with the BD Phoenix™ SMIC/ID panel for the isolation and culture of bacteria from suspected infection patients. This test is intended for use only with the BD Phoenix™ System automated microbial identification and susceptibility testing device.
Dates and status
Registration Date
Oct 30, 2024
About this record

Access comprehensive regulatory information for Screening and sensitivity test for antibiotics of gram-negative aerobic and anaerobic bacteria that are adaptable in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TBYT Loại B medical device is registered under number 240002488/PCBB-HCM and manufactured by Becton, Dickinson and Company (BD). The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BECTON DICKINSON ASIA LIMITED TẠI THÀNH PHỐ HỒ CHÍ MINH.

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