Vietnam MOH registration 240000035/PCBB-LA

HCG Qualitative Test (Early Pregnancy/Quick Test)

VN: Que thử xét nghiệm định tính HCG (Que thử thai phát hiện thai sớm/Nhanh)

Vietnam·Risk Class TBYT Loại B·DK Pregnancy Test Kit; Omeli Pregnancy Test Kit·Company Limited Liability of Vietnam Rubber Technology·Registered Oct 31, 2024

Registration details

Analysis ID: 240000035/PCBB-LA
Submission ID: 000.00.17.H39-241028-0001
Product Type: DK Pregnancy Test Kit; Omeli Pregnancy Test Kit

Company information

Manufacturer: Company Limited Liability of Vietnam Rubber Technology
Product Owner: CÔNG TY TNHH CÔNG NGHỆ CAO SU VIỆT NAM
Authorized Representative: CÔNG TY TNHH CÔNG NGHỆ CAO SU VIỆT NAM

Technical details

Intended Use: The qualitative HCG test (early pregnancy/quick test) is a flow cytometry immunoassay used to qualitatively detect HCG in urine, aiding in the screening and diagnosis of early pregnancy in women.

Dates and status

Registration Date: Oct 31, 2024

About this record

Access comprehensive regulatory information for HCG Qualitative Test (Early Pregnancy/Quick Test) 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 240000035/PCBB-LA and manufactured by Company Limited Liability of Vietnam Rubber Technology. The authorized representative in Vietnam is CÔNG TY TNHH CÔNG NGHỆ CAO SU VIỆT NAM.

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