Vietnam MOH registration 2301693ĐKLH/BYT-HTTB

The qualitative DNA/RNA test kit for 4 types of bacteria, the SARS-CoV-2 virus, and 17 other viruses

VN: Bộ xét nghiệm định tính DNA/RNA của 4 vi khuẩn, vi rút SARS-CoV-2 và 17 vi rút khác

Vietnam·Risk Class TTBYT Loại D·BioFire Respiratory Panel 2.1 (RP2.1)·BioFire Diagnostics, LLC·Registered Dec 22, 2023

Registration details

Analysis ID: 2301693ĐKLH/BYT-HTTB
Submission ID: 19009302/ĐKLH-BYT-TB-CT
Product Type: BioFire Respiratory Panel 2.1 (RP2.1)
Product Code: 423742

Company information

Manufacturer: BioFire Diagnostics, LLC
Manufacturer Country: UNITED STATES

Technical details

Intended Use: The BioFire Respiratory Panel 2.1 (RP2.1) is a multiplex nucleic acid amplification test based on PCR technology, designed to be used with the BioFire® FilmArray® 2.0 or BioFire® FilmArray® Torch Systems to simultaneously identify and qualitatively detect multiple nucleic acids of viruses and bacteria of the respiratory tract in nasopharyngeal swab specimens (NPS) obtained from individuals suspected of having respiratory tract infection, including COVID-19. The following groups and subgroups of respiratory tract bacteria are identified by BioFire RP2.1: Viruses: Adenovirus, Coronavirus 229E, Coronavirus HKU1, Coronavirus NL63, Coronavirus OC43, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Human metapneumovirus, Human rhinovirus/enterovirus, Influenza A virus, Influenza A virus A/H1, Influenza A virus A/H3, Influenza A virus A/H1-2009, Influenza B virus, Parainfluenza virus 1, Parainfluenza virus 2, Parainfluenza virus 3, Parainfluenza virus 4, Respiratory syncytial virus. Bacteria: Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Mycoplasma pneumoniae. The nucleic acids of respiratory tract viruses and bacteria, which are typically detected by this test, can usually be detected in NPS specimens obtained during the acute phase of infection. The detection and identification of the specific nucleic acids of viruses and bacteria from individuals manifesting signs and/or symptoms of respiratory tract infection indicate the presence of the identified bacteria and support the diagnosis of respiratory tract infection if used in combination with clinical and epidemiological information. The results of this test should not be used as the sole basis for diagnosis, treatment, or patient management decisions. Negative results in respiratory tract infection cases may be due to infection with pathogens not detectable by this test or subclinical respiratory tract infection that may not be detectable by NPS specimens. Positive results do not exclude co-infection with other bacteria. The agents detected by BioFire RP2.1 may not be the definitive cause of the disease. Additional laboratory testing (e.g., bacterial and viral culture, fluorescent and X-ray) may be required to evaluate a patient suspected of having a respiratory tract infection.

Dates and status

Registration Date: Dec 22, 2023

About this record

Access comprehensive regulatory information for The qualitative DNA/RNA test kit for 4 types of bacteria, the SARS-CoV-2 virus, and 17 other viruses in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại D medical device is registered under number 2301693ĐKLH/BYT-HTTB and manufactured by BioFire Diagnostics, LLC.

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