适应症和重要安全信息

Failure to use FreeStyle Libre 3 system as instructed in labeling may result in missing a severe low or high glucose event and/or making a treatment decision, 造成伤害. 如果血糖警报和读数不符合症状或预期, 使用血糖仪的指尖值来决定治疗方案. Seek medical attention when appropriate or contact Abbott at 855-632-8658 or FreeStyleLibre.us safety info.

The Lingo portfolio of products are under development and are not intended for medical use. 它们不打算用于筛查, diagnosis, treatment, cure, mitigation, prevention, 或疾病监测, 包括糖尿病. 这些产品不在美国销售.S.

紧急使用授权

BinaxNOW COVID-19 test: The BinaxNOW COVID-19 tests have not been FDA cleared or approved. 它们已经得到了FDA的紧急使用授权. 它们仅被授权用于检测来自SARS-CoV-2的蛋白质, 其他病毒和病原体都不行, 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 根据联邦食品法案第564(b)(1)条, 药品和化妆品法, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

Alinity猴痘PCR检测:本产品尚未获得FDA许可或批准, but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratories; This product has been authorized only for the detection of nucleic acid from monkeypox virus, 其他病毒和病原体都不行; 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 diagnostics for detection and/or diagnosis of infection with the monkeypox virus, including in vitro diagnostics that detect and/or diagnose infection with non-variola Orthopoxvirus, 根据联邦食品法案第564(b)(1)条, Drug, 和化妆品法案, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.