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Coronavirus (COVID | 合法醫療器材資訊網

Coronavirus (COVID

2021年3月31日—Coronavirus(COVID-19)Update:FDAContinuestoAdvanceOver-theCounterandOtherScreeningTestDevelopment·AbbottBinaxNOW ...

 Coronavirus (COVID

For Immediate Release: March 31, 2021

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Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening. In addition to the tests authorized for OTC use, one serial screening test was authorized for use in a point-of-care (POC) setting without a prescription, and an additional screening test was authorized for POC use with a prescription. The addition of the OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable. These ...

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EUA Authorized Serology Test Performance | 合法醫療器材資訊網
2021年5月25日 — Serology tests play a role in the fight against COVID-19 by helping health care ... Abbott Laboratories AdviseDx SARS-CoV-2 IgM (Architect). Read More
Emergency Use Authorizations for Medical Devices | 合法醫療器材資訊網
2021年3月1日 — Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices ... Abbott RealTime Zika (Abbott Molecular Inc.). Read More
Coronavirus (COVID | 合法醫療器材資訊網
2021年3月31日 — Coronavirus (COVID-19) Update: FDA Continues to Advance Over-the Counter and Other Screening Test Development · Abbott BinaxNOW ... Read More
BinaxNOW COVID | 合法醫療器材資訊網
The BinaxNOWTM COVID-19 Ag Card is a lateral flow immunoassay intended for the ... This product has not been FDA cleared or approved; but has been authorized by FDA ... Abbott suggests that you record these controls for each test run. Read More
BinaxNOW COVID | 合法醫療器材資訊網
2021年3月31日 — epidemiological reasons to suspect COVID-19 infection when ... Page 2 – Angela Drysdale, Abbott Diagnostics Scarborough, Inc. FDA considered the totality of scientific information available in authorizing the emergency use. Read More
Coronavirus (COVID | 合法醫療器材資訊網
2020年12月16日 — The BinaxNOW COVID-19 Ag Card Home Test is authorized for prescription use at home with self-collected nasal swab samples from individuals ... Read More
Fact Sheet for Recipients | 合法醫療器材資訊網
COVID-19 is available at the CDC General webpage: https://www.cdc.gov/​COVID19. In addition, please also ... SARS-CoV-2 IgG assay - Abbott Laboratories Inc. December 1, 2020 ... cleared tests available, and other criteria are met, FDA. Read More
ID NOW COVID | 合法醫療器材資訊網
2020年9月17日 — who are suspected of COVID-19 by their healthcare provider ... 2020, FDA granted your request to update the authorized labeling.3 On June 1, 2020, based ... Page 2 – Angela Drysdale, Abbott Diagnostics Scarborough, Inc. Read More
Abbott's Covid | 合法醫療器材資訊網
2021年4月1日 — Abbott's Covid-19 antigen test gets FDA authorisation for asymptomatic use ... The US Food and Drug Administration (FDA) has granted ... Read More
Abbott's BinaxNOW™ Rapid Antigen Self Test Receives FDA ... | 合法醫療器材資訊網
2021年3月31日 — The BinaxNOW COVID-19 Ag tests have not been FDA cleared or approved. They have been authorized by the FDA under an emergency use ... Read More
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