Vietnam MOH registration 2400214ĐKLH/BYT-HTTB

Total Prostate Specific Antigen (t-PSA) Quantitative Test Kit

VN: Bộ xét nghiệm định lượng Total Prostate Specific Antigen (t-PSA)

Vietnam·Risk Class TTBYT Loại C·Total PSA ELISA·DRG Instruments GmbH·Registered Feb 04, 2024

Registration details

Analysis ID: 2400214ĐKLH/BYT-HTTB
Submission ID: 17003676/ĐKLH-BYT-TB-CT
Product Type: Total PSA ELISA

Company information

Manufacturer: DRG Instruments GmbH
Manufacturer Country: GERMANY
Product Owner: DRG Instruments GmbH
Authorized Representative: CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA

Technical details

Intended Use: The DRG PSA Total ELISA test is used to quantify the total amount of prostate-specific antigen (t-PSA) in human serum or plasma samples (EDTA, lithium heparin, or citrate plasma).

Dates and status

Registration Date: Feb 04, 2024

About this record

Access comprehensive regulatory information for Total Prostate Specific Antigen (t-PSA) Quantitative Test Kit 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 2400214ĐKLH/BYT-HTTB and manufactured by DRG Instruments GmbH. The authorized representative in Vietnam is CÔNG TY TNHH THƯƠNG MẠI Y TẾ PHÚ GIA.

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