Nano-Check TM COVID-19 Antigen Test

The Nano-CheckTM COVID-19 Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal swab and direct nasopharyngeal swab specimens collected from individuals who are suspected of COVID-19 by their healthcare provider within the first five (5) days of symptoms onset when tested at least twice over three days with at least 48 hours between tests or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested at least three times over five days with at least 48 hours between tests.

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, high or waived complexity tests. This product 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.

For use under emergency use authorization (EUA) only For in vitro diagnostic use For prescription use only For use with kit provided nasopharyngeal swab Lateral flow assay Detect SARS-CoV-2 nucleocapsid protein antigen Rapid results within 15-20 minutes

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Link for downloading documents

• FACT SHEET FOR HEALTHCARE PROVIDERS
• FACT SHEET FOR PATIENTS
• IFU (INSTRUCTIONS FOR USE)
• FDA EMERGENCY USE AUTHORIZATION
• MSDS
• 02 - EUA210170.S001.Nano Ditech Letter Granting EUA Revision 02-01-2022