The BinaxNOW™ COVID-19 tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use authorization. They have been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner. For serial testing, the BinaxNOW COVID-19 Antigen Tests should be performed twice over 3 days, at least 24 hours (and no more than 48 hours) apart. For symptomatic use, a single test can be used.

For use under an Emergency Use Authorization only.

• This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only.
• Use of the Alinity m Resp-4-Plex assay is limited to personnel who have been trained in the procedures of a molecular diagnostic assay and the Alinity m System.
• Laboratories are required to report all SARS-CoV-2 results to the appropriate public health authorities.
• The instrument and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from positive controls or specimens must be controlled by good laboratory practices and careful adherence to the procedures specified in this package insert.
• Optimal performance of this test requires appropriate specimen collection, storage, and transport to the test site (refer to the SPECIMEN COLLECTION, STORAGE, AND TRANSPORT TO THE TEST SITE section of this package insert).
• Detection of flu A, flu B, RSV, or SARS-CoV-2 RNA may be affected by sample collection methods, patient factors (eg, presence of symptoms), and/or stage of infection.
• Recent patient exposure to FluMist® or other attenuated influenza vaccines may cause inaccurate positive results for flu A and flu B due to the presence of attenuated viruses.
• False-negative results may arise from degradation of the viral RNA during storage and transport of the specimens.
• As with any molecular test, mutations within the target regions of Alinity m Resp-4-Plex assay could affect primer and/or probe binding resulting in failure to detect the presence of virus.
• Results should be interpreted by a trained professional in conjunction with the patient's history and clinical signs and symptoms, and epidemiological risk factors.
• Negative results do not preclude infection with the flu A, flu B, RSV, or SARS-CoV-2 and should not be the sole basis of a patient treatment/management or public health decision. Follow up testing should be performed according to the current CDC recommendations.
• Self-collected under supervision of or healthcare provider collected nasal swabs are additional acceptable upper respiratory specimens that can be tested with the Alinity m Resp-4-Plex assay; however, performance with this specimen type has not been validated.
• Influenza was validated in the clinical study by testing archived, selected specimens only. If an influenza result is inconsistent with clinical presentation and/or other clinical and epidemiological information, FDA-cleared Influenza NAATs are available for confirmation if clinically indicated.
• A positive result indicates the detection of nucleic acid from the relevant virus. Nucleic acid may persist even after the virus is no longer viable.

FDA EMERGENCY USE AUTHORIZATION

This product has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use by authorized laboratories;

• This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
• The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older.*

WARNINGS/LIMITATIONS*:

The System must not be used with automated insulin dosing (AID) systems, including closed loop and insulin suspend systems. Remove the sensor before MRI, CT scan, X-ray, or diathermy treatment. Do not take high doses of vitamin C (more than 500 mg per day), as this may falsely raise your Sensor readings. Failure to use the System according to the instructions for use may result in missing a severe low blood glucose or high blood glucose event and/or making a treatment decision that may result in injury. If glucose alarms and readings from the System do not match symptoms or expectations, use a fingerstick blood glucose value to make diabetes treatment decisions. Seek medical attention when appropriate and contact Abbott Toll Free (855-632-8658) or visit * www.freestylelibre.us for detailed indications for use and safety information.

*Please refer to www.freestylelibre.us for the indications and important safety information.