Vietnam MOH registration 240002229/PCBB-HCM

IVD Environment-Recognizing Labeling Cluster

VN: Cụm IVD định danh môi trường miễn dịch

Vietnam·Risk Class TBYT Loại B·Theo theo phụ lục·Rapid Labs Limited·Registered Sep 30, 2024

Registration details

Analysis ID: 240002229/PCBB-HCM
Submission ID: 000.00.19.H29-240924-0001
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Rapid Labs Limited
Manufacturer Country: Theo theo phụ lục
Product Owner: Rapid Labs Limited
Authorized Representative: CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ VIMEC

Technical details

Intended Use: - The Febrile Antigen Kit is used for agglutination tests on slides and in test tubes to detect the presence of plasma agglutinins (O, H) in the plasma of patients with epidemic and endemic typhus. - The Brucella Antigen Kit is used for slide and test tube tests to detect specific antibodies against Brucella abortus and Brucella melitensis in human and animal plasma.

Dates and status

Registration Date: Sep 30, 2024

About this record

Access comprehensive regulatory information for IVD Environment-Recognizing Labeling Cluster 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 240002229/PCBB-HCM and manufactured by Rapid Labs Limited. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN THIẾT BỊ Y TẾ VIMEC.

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