Vietnam MOH registration 240001996/PCBB-HN

In vitro rapid diagnostic test kit for the detection of β-lactamase CTX-M-14 and CTX-M-15 in bacterial cultures

VN: Bộ xét nghiệm chẩn đoán nhanh in vitro phát hiện β-lactamase CTX-M-14 và CTX-M-15 trong nuôi cấy vi khuẩn
Vietnam flagVietnam·Risk Class TBYT Loại B·K-15R14·Coris Bioconcept·Registered Aug 08, 2024
Registration details
Analysis ID
240001996/PCBB-HN
Submission ID
000.00.19.H26-240725-0020
Product Type
K-15R14
Product Code
K-15R14
Company information
Manufacturer
Coris Bioconcept
Product Owner
Coris BioConcept
Technical details
Intended Use
Used to detect β-lactamase group 1 (CTX-M-15-like), group 8 (CTX-M-8-like), and group 9 (CTX-M-14-like) from the Enterobacteriaceae bacterial population grown on the agar plate.
Dates and status
Registration Date
Aug 08, 2024
About this record

Access comprehensive regulatory information for In vitro rapid diagnostic test kit for the detection of β-lactamase CTX-M-14 and CTX-M-15 in bacterial cultures 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 240001996/PCBB-HN and manufactured by Coris Bioconcept. The authorized representative in Vietnam is CÔNG TY TNHH THIẾT BỊ KHOA HỌC VIỆT ANH.

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