Vietnam MOH registration 240001099/PCBB-HCM

IVD Department Quantitative Insulin Testing

VN: Bộ IVD xét nghiệm định lượng Insulin

Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Beckman Coulter, Inc.·Registered May 29, 2024

Registration details

Analysis ID: 240001099/PCBB-HCM
Submission ID: 000.00.19.H29-240408-0003
Product Type: Theo theo phụ lục
Product Code: Theo phụ lục

Company information

Manufacturer: Beckman Coulter, Inc.
Manufacturer Country: Theo theo phụ lục
Product Owner: Beckman Coulter, Inc.
Authorized Representative: VĂN PHÒNG ĐẠI DIỆN BECKMAN COULTER HONG KONG LIMITED TẠI TPHCM

Technical details

Intended Use: 1/ ACCESS ULTRASENSITIVE INSULIN: It is a fluorescent chemiluminescence immunoassay for the quantitative determination of insulin in human serum and plasma (EDTA). 2/ ACCESS ULTRASENSITIVE INSULIN CALIBRATORS: Used to calibrate the Access ultra-sensitive insulin assay for the quantitative determination of insulin in human serum and plasma (EDTA) by the Access Immunoassay System.

Dates and status

Registration Date: May 29, 2024

About this record

Access comprehensive regulatory information for IVD Department Quantitative Insulin 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 240001099/PCBB-HCM and manufactured by Beckman Coulter, Inc.. The authorized representative in Vietnam is VĂN PHÒNG ĐẠI DIỆN BECKMAN COULTER HONG KONG LIMITED TẠI TPHCM.

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