Vietnam MOH registration 240001384/PCBB-HCM

IVD Cluster Bacterial Sensitivity Testing

VN: Cụm IVD Xét nghiệm tính mẫn cảm của vi khuẩn

theo phụ lục

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·BIOANALYSE TIBBİ MALZEME SANAYİ VE TİCARET LİMİTED ŞİRKETİ·Registered Jul 03, 2024

Registration details

Analysis ID: 240001384/PCBB-HCM
Submission ID: 000.00.19.H29-240628-0012
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: BIOANALYSE TIBBİ MALZEME SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Manufacturer Country: Theo theo phụ lục
Product Owner: BIOANALYSE TIBBİ MALZEME SANAYİ VE TİCARET LİMİTED ŞİRKETİ
Authorized Representative: CÔNG TY TNHH THIẾT BỊ KHOA HỌC KỸ THUẬT QUANG PHÁT

Technical details

Intended Use: 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

Registration Date: Jul 03, 2024

About this record

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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