Vietnam MOH registration 240001691/PCBB-HCM

IVD Cluster: Testing the sensitivity of bacteria to a number of antibiotics

VN: Cụm IVD Xét nghiệm tính nhạy cảm của vi khuẩn với một số thuốc kháng sinh
Vietnam flagVietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Oxoid Limited·Registered Aug 05, 2024
Registration details
Analysis ID
240001691/PCBB-HCM
Submission ID
000.00.19.H29-240710-0014
Product Type
Theo theo phụ lục
Product Code
Theo phụ lục
Company information
Manufacturer
Oxoid Limited
Manufacturer Country
Theo theo phụ lục
Product Owner
Oxoid Limited
Technical details
Intended Use
*The products: CT1653B; CT0005B; CT0149B; CT0665B; CT1941B; CT1942B; CT1947B; CT1948B; CT1662B; CT0693B; CT1880B; CT0067B; CT0466B; CT0225B; CT0661B; CT0047B; CT1897B; CT0167B: The Thermo Scientific™ Oxoid™ Antimicrobial Susceptibility Test (AST) Discs are used in the diffusion agar semiquantitative method to determine the in vitro susceptibility of microorganisms. *The products: CT0107B; CT0538B; CT0223B; CT0002B; CT0003B; CT0520B; CT0906B; CT0264B; CT0453B; CT0771B; CT0653B; CT0249B; CT0166B; CT0407B; CT0119B; CT1612B; CT0412B; CT1629B; CT0417B; CT0127B; CT0007B; CT0011B; CT0013B; CT0425B; CT0064B; CT0018B; CT1761B; CT0020B; CT0758B; CT0023B; CT0024B; CT0072B; CT0455B; CT0026B; CT1587B; CT1649B; CT0096B; CT0774B; CT1949B; CT0030B; CT1633B; CT0523B; CT0031B; CT0034B; CT0036B; CT0434B; CT0446B; CT0159B; CT0152B; CT0199B; CT1619B; CT0725B; CT1616B; CT0207B; CT0052B; CT0647B; CT0054B; CT1841B; CT0056B; CT0076B; CT0058B; CT0188B: The Thermo Scientific™ Oxoid™ Antimicrobial Susceptibility Test Discs are used in the diffusion agar semiquantitative method to determine the in vitro susceptibility of microorganisms. They are used in the diagnostic process to assist the clinical microbiologist in determining potential treatment options for patients suspected of being infected. These discs aim to determine the susceptibility of the microorganisms to the specific antibiotics that have been proven to be active both clinically and in vitro. They are intended to be used in conjunction with the pure culture agar method. The specific purpose of each product in the AST Disc range can be found in the electronic supplementary manual for the relevant antibiotic.
Dates and status
Registration Date
Aug 05, 2024
About this record

Access comprehensive regulatory information for IVD Cluster: Testing the sensitivity of bacteria to a number of antibiotics in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240001691/PCBB-HCM and manufactured by Oxoid Limited. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN LIFE TECHNOLOGIES HOLDINGS PTE. LTD. TẠI THÀNH PHỐ HỒ CHÍ MINH.

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