IVD Cluster for the detection of antibiotic resistance in gram-negative bacteria
Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Bd·Registered Oct 30, 2024- Analysis ID
- 240002489/PCBB-HCM
- Submission ID
- 000.00.19.H29-241011-0025
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
- Manufacturer
- Bd
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Bd
- Authorized Representative
- VĂN PHÒNG ĐẠI DIỆN BECTON DICKINSON ASIA LIMITED TẠI THÀNH PHỐ HỒ CHÍ MINH
- Intended Use
- 449023: The BD Phoenix™ NMIC-500 antibiotic susceptibility test is used to determine the susceptibility of gram-negative aerobic and facultative anaerobic bacteria of human origin (for a complete list of bacteria, refer to the BD Phoenix™ System Manual) to the selected antibiotics. The BD Phoenix™ System is a fully automated system that functions as a diagnostic tool, providing quantitative susceptibility test results, automatically, when used in conjunction with the BD Phoenix™ NMIC panel for the isolation and identification of bacteria from clinical specimens suspected of being infected. This test is intended for use only with the BD Phoenix™ System. 448764: The BD Phoenix™ NMIC-203 antibiotic susceptibility test is used to determine the susceptibility of gram-negative aerobic and facultative anaerobic bacteria of human origin (for a complete list of bacteria, refer to the BD Phoenix™ System Manual) to the selected antibiotics. The BD Phoenix™ System is a fully automated system that functions as a diagnostic tool, providing quantitative susceptibility test results, automatically, when used in conjunction with the BD Phoenix™ NMIC panel for the isolation and identification of bacteria from clinical specimens suspected of being infected. This test is intended for use only with the BD Phoenix™ System.
- Registration Date
- Oct 30, 2024
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Access comprehensive regulatory information for IVD Cluster for the detection of antibiotic resistance in gram-negative bacteria 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 240002489/PCBB-HCM and manufactured by 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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