Vietnam MOH registration 2300564ĐKLH/BYT-HTTB

Qualitative RSV Antigen Test

VN: Thanh thử xét nghiệm định tính kháng nguyên RSV

Vietnam·Risk Class TTBYT Loại C·BinaxNOW™ RSV Card·Abbott Diagnostics Scarborough, Inc.·Registered Jun 20, 2023

Registration details

Analysis ID: 2300564ĐKLH/BYT-HTTB
Submission ID: 000.00.04.G18-210820-0024
Product Type: BinaxNOW™ RSV Card
Product Code: 430-022

Company information

Manufacturer: Abbott Diagnostics Scarborough, Inc.
Manufacturer Country: UNITED STATES

Technical details

Intended Use: BinaxNOW™ RSV Card is an immuno-chromatographic qualitative test for the detection of respiratory tract cell fusion virus protein (RSV) antigens in nasopharyngeal wash specimens and nasopharyngeal swabs from symptomatic patients. The test serves a diagnostic purpose in the laboratory to assist in the diagnosis of viral respiratory tract infections in infants and young children under 5 years of age. A negative test result should be confirmed by cell culture.

Dates and status

Registration Date: Jun 20, 2023

About this record

Access comprehensive regulatory information for Qualitative RSV Antigen Test 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 2300564ĐKLH/BYT-HTTB and manufactured by Abbott Diagnostics Scarborough, Inc..

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