IVD Cluster Bacterial Sensitivity Testing - Vietnam Registration 240001384/PCBB-HCM
Access comprehensive regulatory information for IVD Cluster Bacterial Sensitivity Testing 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 240001384/PCBB-HCM and manufactured by BIOANALYSE TIBBİ MALZEME SANAYİ VE TİCARET LİMİTED ŞİRKETİ. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KHOA HỌC KỸ THUẬT QUANG PHÁT.
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Device Details
Registration Details
240001384/PCBB-HCM
000.00.19.H29-240628-0012
Theo theo phụ lục
Theo phụ lục
Technical Details
The susceptibility test disk, designed for use in clinical laboratories and used manually with the diffusion semiquantitative test method, is used to support clinical physicians in the management of patients and to determine potential treatment options in patients suspected of being infected with bacteria. It can be used in infections caused by difficult-to-grow and/or easily grown bacteria. It is prepared on a pure agar medium using standard strains and/or can be used for quality control purposes. The test provides information to classify bacteria as resistant, moderately susceptible, or susceptible to antibiotics.
Dates and Status
Jul 03, 2024