Vietnam MOH registration 240000027/PCBA-LA

Endocervical Sampling Kit for Cervical Cancer Screening

VN: Bộ dụng cụ thu mẫu cho tầm soát ung thư cổ tử cung

TopPURE ® HPV Pap Smear Kit

Vietnam·Risk Class TTBYT Loại A·In-vitro cell sampling kit·ABT Biotech Solution Co., Ltd. - Long Hậu Branch·Registered Mar 12, 2024

Registration details

Analysis ID: 240000027/PCBA-LA
Submission ID: 000.00.17.H39-240307-0001
Product Type: In-vitro cell sampling kit
Product Code: HI-017

Company information

Manufacturer: ABT Biotech Solution Co., Ltd. - Long Hậu Branch
Manufacturer Country: VIET NAM
Product Owner: CÔNG TY TNHH GIẢI PHÁP Y SINH ABT- CHI NHÁNH LONG HẬU
Authorized Representative: CÔNG TY TNHH GIẢI PHÁP Y SINH ABT- CHI NHÁNH LONG HẬU

Technical details

Intended Use: Used for the collection and storage of cervical cytology specimens for the purpose of cervical cancer screening (pap smear), the sample can also be processed for the detection of HPV-DNA. The slide is provided for the performance of the test

Dates and status

Registration Date: Mar 12, 2024

About this record

Access comprehensive regulatory information for Endocervical Sampling Kit for Cervical Cancer Screening in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại A medical device is registered under number 240000027/PCBA-LA and manufactured by ABT Biotech Solution Co., Ltd. - Long Hậu Branch. The authorized representative in Vietnam is CÔNG TY TNHH GIẢI PHÁP Y SINH ABT- CHI NHÁNH LONG HẬU.

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