GenBody Inc.
GenBody COVID-19 Ag Test
GenBody COVID-19 Ag Test
For In Vitro Diagnostic Use. For Prescription Use Only. For Professional Use Only. For Emergency Use Authorization (EUA) Only.
The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) or anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 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.
KEY BENEFITS:
- Anterior nasal swab specimen collection for comfort
- Identifies acute infection with a 92.31% sensitivity and 99.04 specificity
- Results in only 15-20 minutes
NUMBER OF TESTS: Twenty-five (25) single use, individually pouched, test devices
STORAGE CONDITIONS: Store between 35.6 to 86 °F (2 to 30 °C). Before test administration and quality control testing, let the test materials equilibrate to room temperature at 59°-86°F (15°-30°C). Do not expose the test devices and extraction solutions to temperatures outside of room temperature during testing.
CPT CODE: 87811QW
DOCUMENTATION:
FACT SHEET FOR HEALTHCARE PROVIDERS
EMERGENCY USE AUTHORIZATION (EUA) LETTER
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