BD 445366 - Molecular Reagent BD MAX™… | USA MedPremium
Molecular Reagent BD MAX™ SARS-CoV-2, Influenza A / B, Respiratory Syncytial Virus (RSV) CLIA Non-Waived For BD MAX System 1,920 Tests
USAMP#38012869SKU: 445366BD MAX™
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BD MAX RVP, 80 Pack, 1920 Test Kit
BD Respiratory Viral Panel for BD MAX System is for use under an FDA EUA: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2
This test is authorized for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A, influenza B, and/or respiratory syncytial virus (RSV) in nasopharyngeal and anterior nasal swab specimens collected from individuals with signs and symptoms of respiratory tract infection consistent with COVID-19
Emergency use of this test is limited to authorized laboratories
Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform moderate or high complexity tests
Positive results are indicative of nucleic acid but do not rule out bacterial infection or co-infection with other pathogens not detected by the test; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
Laboratories within the United States and its territories are required to report all SARS-CoV-2 results to the appropriate public health authorities
Negative results do not preclude SARS-CoV-2, influenza A, influenza B, and/or RSV infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations, patient history, and/or epidemiological information
Required but not Provided: BD MAX™ System with Software Version 5.14 or later (BD Catalog Number 441916), BD MAX™ Sample Rack (BD Catalog Number 444807 or 444808), BD PCR Cartridges (BD Catalog Number 437519)
