Sekisui Diagnostics #MTRX-C19-25PK Respiratory Test Kit Metrix™ COVID-19 25 Tests TEST KIT, COVID-19 APTITUDE METRIX (25/KT) D/S Features The Metrix COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2 The Metrix™ COVID-19 Test (Metrix) is a single-use molecular in vitro diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19 This test is authorized for non-prescription home use with anterior nasal (nares) swab and saliva specimens, self-collected from any individual aged 14 years or older, or adult-collected from any individual aged 2 years or older, including individuals without symptoms or other epidemiological reasons to suspect COVID-19 Positive results indicate the presence of viral RNA, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status Positive results do not rule out bacterial infection or co-infection with other viruses. Individuals who test positive with the Metrix COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary Negative results from saliva samples are presumptive and should be confirmed by molecular testing of an alternative sample type if clinically indicated; negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or management decisions for the individual, including infection control decisions Requires Metrix Reader (not included) Metrix is the first OTC molecular test authorized by FDA to work with saliva or swab sample Manufacturer # MTRX-C19-25PK Brand Metrix™ Manufacturer Sekisui Diagnostics Country of Origin Unknown Application Respiratory Test Kit Contents 1 Cap, Collector, Swab, Sensor, Quick Ref Instruction For Use With For Metrix Reader Number of Tests 25 Tests Product Dating Acceptable Dating: we will ship >= 60 days Purchase Program Type Standard Purchase Reading Type Machine Read Sample Type Nasal Swab / Saliva Sample Specialty Molecular Technology Nucleic Acid Amplification Technology (NAAT) Test Format Test Device Format Test Kit Type Rapid Test Method Multi-gene Amplification Test Name COVID-19 Time to Results 30 Minute Results UNSPSC Code 41116144
Sekisui Diagnostics #MTRX-C19-25PK Respiratory Test Kit Metrix™ COVID-19 25 Tests TEST KIT, COVID-19 APTITUDE METRIX (25/KT) D/S Features The Metrix COVID-19 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2 The Metrix™ COVID-19 Test (Metrix) is a single-use molecular in vitro diagnostic test for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19 This test is authorized for non-prescription home use with anterior nasal (nares) swab and saliva specimens, self-collected from any individual aged 14 years or older, or adult-collected from any individual aged 2 years or older, including individuals without symptoms or other epidemiological reasons to suspect COVID-19 Positive results indicate the presence of viral RNA, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status Positive results do not rule out bacterial infection or co-infection with other viruses. Individuals who test positive with the Metrix COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary Negative results from saliva samples are presumptive and should be confirmed by molecular testing of an alternative sample type if clinically indicated; negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for treatment or management decisions for the individual, including infection control decisions Requires Metrix Reader (not included) Metrix is the first OTC molecular test authorized by FDA to work with saliva or swab sample Manufacturer # MTRX-C19-25PK Brand Metrix™ Manufacturer Sekisui Diagnostics Country of Origin Unknown Application Respiratory Test Kit Contents 1 Cap, Collector, Swab, Sensor, Quick Ref Instruction For Use With For Metrix Reader Number of Tests 25 Tests Product Dating Acceptable Dating: we will ship >= 60 days Purchase Program Type Standard Purchase Reading Type Machine Read Sample Type Nasal Swab / Saliva Sample Specialty Molecular Technology Nucleic Acid Amplification Technology (NAAT) Test Format Test Device Format Test Kit Type Rapid Test Method Multi-gene Amplification Test Name COVID-19 Time to Results 30 Minute Results UNSPSC Code 41116144
