Clarity Diagnostics COV19AG-VIS Rapid Test Kit, Antigen Detection, Covid-19

Features

Clarity Diagnostics COV19AG-VIS Rapid Test Kit, Antigen Detection, Covid-19

Clarity Diagnostics Rapid Test Kit, Antigen Detection, Covid-19 (MFR # COV19AG-VIS) is a medical supplies. Sold by Default Title.

Key Features

• The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is only for use under the Food and Drug Administration's Emergency Use Authorization: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
• This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet the requirements to perform moderate complexity, high complexity, or waived tests
• The Sienna-Clarity COVID-19 Antigen Rapid Test Cassette is a rapid chromatographic immunoassay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swab (NP) specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset
• Laboratories within the United States and its territories are required to report all results to the appropriate public health laboratories
• For prescription use only
• Positive results indicate the presence of viral antigens, but clinical correlation with patient 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

Specifications

• Brand: Clarity Diagnostics
• Manufacturer Part #: COV19AG-VIS
• SKU: CLA-COV19AG-VIS (Default Title)
• Product Type: Medical Supplies
• UPC: 41116205
• Country of Origin: Finland
• Packaging: sold by Default Title