Vietnam MOH registration 2300794ĐKLH/BYT-HTTB

Qualitative DNA/RNA test for 13 bacteria, 5 viruses, and 4 parasites

VN: Bộ xét nghiệm định tính DNA/RNA của 13 vi khuẩn, 5 vi rút, 4 ký sinh trùng

Vietnam·Risk Class TTBYT Loại C·FilmArray Gastrointestinal (GI) Panel·BioFire Diagnostics, LLC·Registered Aug 21, 2023

Registration details

Analysis ID: 2300794ĐKLH/BYT-HTTB
Submission ID: 19009303/ĐKLH-BYT-TB-CT
Product Type: FilmArray Gastrointestinal (GI) Panel
Product Code: RFIT-ASY-0104/RFIT-ASY-0116

Company information

Manufacturer: BioFire Diagnostics, LLC
Manufacturer Country: UNITED STATES

Technical details

Intended Use: The BioFire® FilmArray® Gastrointestinal (GI) Panel is an in vitro diagnostic nucleic acid amplification test designed to be used with the BioFire® FilmArray® systems. The BioFire GI Panel can simultaneously detect and identify the nucleic acid from bacteria, viruses, and parasites directly from the stool sample in the Cary Blair transport medium taken from individuals with signs and/or symptoms of gastrointestinal infection. The following bacteria (including some enteropathogenic E. coli/Shigella groups), parasites, and viruses were identified by the BioFire GI Panel: • Campylobacter (C. jejuni/C. coli/C. upsaliensis) • Clostridium difficile (C. difficile) toxins A/B • Plesiomonas shigelloides • Salmonella • Vibrio (V. parahaemolyticus/V. vulnificus/ V. cholerae), including specific identification of Vibrio cholerae • Yersinia enterocolitica • Escherichia coli causing enterocolitis (EAEC) • Escherichia coli causing diarrhea (EPEC) • Escherichia coli causing enterotoxemia (ETEC) lt/st • Escherichia coli causing hemolysis (EHEC) stx1/stx2 (including specific identification of O157 E. coli in EHEC) • Shigella/Escherichia coli causing enterocolitis (EIEC) • Cryptosporidium • Cyclospora cayetanensis • Entamoeba histolytica • Giardia lamblia (also known as G. intestinalis and G. duodenalis) • Adenovirus F 40/41 • Astrovirus • Norovirus GI/GII • Rotavirus A • Sapovirus (Groups I, II, IV, and V) The BioFire GI Panel is intended as a tool to aid in the identification of specific pathogens causing gastrointestinal infections, and therefore the results should be considered in conjunction with other clinical, laboratory, and epidemiological findings. Positive results do not rule out the possibility of co-infection with uncharacterized organisms in the BioFire GI Panel. The identified organisms may not be the definitive cause of the infection. Concurrent culture is required to identify the organisms and to further characterize the bacterial pathogens. This device is not intended to monitor or guide the treatment of Clostridium difficile infections.

Dates and status

Registration Date: Aug 21, 2023

About this record

Access comprehensive regulatory information for Qualitative DNA/RNA test for 13 bacteria, 5 viruses, and 4 parasites 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 2300794ĐKLH/BYT-HTTB and manufactured by BioFire Diagnostics, LLC.

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