Vietnam MOH registration 2402923ĐKLH/BYT-HTTB

Standardized Assay for Quantitative CKMB, CK

VN: Chất hiệu chuẩn xét nghiệm định lượng CKMB, CK

Vietnam·Risk Class TTBYT Loại C·Dimension CKI/MBI Calibrator (Name on Label: Dimension CKI/MBI CAL)·Siemens Healthcare Diagnostics Inc.·Registered Oct 22, 2024

Registration details

Analysis ID: 2402923ĐKLH/BYT-HTTB
Submission ID: 17001944/ĐKLH-BYT-TB-CT
Product Type: Dimension CKI/MBI Calibrator (Name on Label: Dimension CKI/MBI CAL)
Product Code: DC32 10464508

Company information

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer Country: UNITED STATES
Authorized Representative: CÔNG TY TNHH SIEMENS HEALTHCARE

Technical details

Intended Use: CKI/MBI CAL is an in vitro diagnostic reagent for calibrating Creatine Kinase (CKI) and Creatine Kinase MB (MBI) methods in the Dimension clinical laboratory system

Dates and status

Registration Date: Oct 22, 2024

About this record

Access comprehensive regulatory information for Standardized Assay for Quantitative CKMB, CK in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại C medical device is registered under number 2402923ĐKLH/BYT-HTTB and manufactured by Siemens Healthcare Diagnostics Inc.. The authorized representative in Vietnam is CÔNG TY TNHH SIEMENS HEALTHCARE.

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