Sekisui Diagnostics #MTRX-C19-B1 Respiratory Test Kit Metrix™ COVID-19 Bundle 50 Tests TEST KIT, COVID-19 APTITUDE METRIX TESTS&READER (50TEST/KT) Features Metrix™ COVID-19 Test & Reader Starter Bundle - includes 2 Metrix COVID-19 Test Kits ( 1244258 - MTRX-C1925PK) and 1 reusable Metrix Reader (1244259 - MTRX-RDR) 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 Metrix is the first OTC molecular test authorized by FDA to work with saliva or swab sample Metrix Reader is intelligent: Metrix Reader comes with Bluetooth and WiFi modules; in the near future, you can access the test results of your reader anywhere, and receive tailored suggestions Works with a standard USB-C plug or a battery pack The Metrix COVID-19 test has not been FDA-cleared or approved; it has been authorized by the FDA under an Emergency Use Authorization (EUA) For external QCs see 1245689 (RED-S-19/99-P-01) Manufacturer # MTRX-C19-B1 Brand Metrix™ Manufacturer Sekisui Diagnostics Country of Origin Unknown Application Respiratory Test Kit Contents 1 (1) Metrix Reader, (2) Metrix COVID-19 Test Kits (25 Tests per Kit), Power Adapter, USB-C Power Cord, Quick Start Guide For Use With For Metrix COVID-19 Test Number of Tests 50 Tests Product Dating Acceptable Dating: we will ship >= 90 days Purchase Program Type Starter Kit 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 Bundle Time to Results 30 Minute Results UNSPSC Code 41116144
Sekisui Diagnostics #MTRX-C19-B1 Respiratory Test Kit Metrix™ COVID-19 Bundle 50 Tests TEST KIT, COVID-19 APTITUDE METRIX TESTS&READER (50TEST/KT) Features Metrix™ COVID-19 Test & Reader Starter Bundle - includes 2 Metrix COVID-19 Test Kits ( 1244258 - MTRX-C1925PK) and 1 reusable Metrix Reader (1244259 - MTRX-RDR) 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 Metrix is the first OTC molecular test authorized by FDA to work with saliva or swab sample Metrix Reader is intelligent: Metrix Reader comes with Bluetooth and WiFi modules; in the near future, you can access the test results of your reader anywhere, and receive tailored suggestions Works with a standard USB-C plug or a battery pack The Metrix COVID-19 test has not been FDA-cleared or approved; it has been authorized by the FDA under an Emergency Use Authorization (EUA) For external QCs see 1245689 (RED-S-19/99-P-01) Manufacturer # MTRX-C19-B1 Brand Metrix™ Manufacturer Sekisui Diagnostics Country of Origin Unknown Application Respiratory Test Kit Contents 1 (1) Metrix Reader, (2) Metrix COVID-19 Test Kits (25 Tests per Kit), Power Adapter, USB-C Power Cord, Quick Start Guide For Use With For Metrix COVID-19 Test Number of Tests 50 Tests Product Dating Acceptable Dating: we will ship >= 90 days Purchase Program Type Starter Kit 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 Bundle Time to Results 30 Minute Results UNSPSC Code 41116144
