Screening and sensitivity test for the antibiotic resistance of Streptococcus - Vietnam Registration 240002634/PCBB-HCM
Access comprehensive regulatory information for Screening and sensitivity test for the antibiotic resistance of Streptococcus 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 240002634/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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Device Details
Registration Details
240002634/PCBB-HCM
000.00.19.H29-241025-0029
BD Phoenix™ SMIC/ID-2
448851
Technical Details
BD Phoenix™ SMIC/ID is used to quickly identify and test the sensitivity of most Streptococcus species of human origin to the selected antibiotics (for a complete list of microorganisms, refer to the BD Phoenix™ System Manual). The BD Phoenix™ automated bacterial identification system functions as a diagnostic tool, providing qualitative and quantitative antibiotic sensitivity test results, when used in conjunction with the BD Phoenix™ SMIC/ID panel for the isolation and cultivation of bacteria from suspected infected patients. This test is intended for use only with the BD Phoenix™ automated bacterial identification system.
Dates and Status
Nov 20, 2024