COVID: CareStart Covid-19 Rapid Antigen Test: 20 tests/box - expiration 06.30.2023

CareStart SARS-CoV-2 Antigen Test Each box contains 20 tests.  Lot: CP21K69  The lot is marked with an expiration date of 3/22, however the expiration had been extended by the FDA to 06.30.2023.  The CareStart™ COVID-19 Antigen Test is a lateral flow immunochromatographic assay intended for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal or anterior nasal swab specimens directly collected from individuals who are either suspected of COVID-19 by their healthcare provider within the first five 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 test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. NOTE: For Serial Screening of asymptomatic individuals. The serial screening indication is only applied to products manufactured by Access Bio Inc. after April 12, 2021. As of December 2nd, 2021, the FDA has granted an additional shelf-life extension for CareStart , from twelve months to sixteen (16) months. Please view the Official Notification Letter for more information on expiration dates. Manufacturer's Description Regulatory Status: FDA EUA Authorized : this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories.