FDA COVID | 合法醫療器材資訊網

,2020年12月30日—TheFDAiscommittedtohelpingensurethepublichasaccesstoawidevarietyoftestoptionsforCOVID-19.Sincethestartofthepandemic, ...,2020年11月17日—TheFDAissuedanemergencyuseauthorizationforthefirstCOVID-19diagnostictestthatallowsforself-collectionandtestingathomeand ...,7天前—MolecularSARS-CoV-2DiagnosticTestsforCOVID-19thathavebeen...WithgrantingoftheDeNovofortheBioFireRP2.1,theFDArevokedtheEUAforthis...02/03/2021,DiaCarta,Inc,QuantiVirusSARS-CoV-2Testkit,Q:Whatinvitrodiagnostictestsfo...

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Removal Lists of Tests that Should No Longer Be Used andor ... | 合法醫療器材資訊網

COVID | 合法醫療器材資訊網

2020年12月30日 — The FDA is committed to helping ensure the public has access to a wide variety of test options for COVID-19. Since the start of the pandemic, ... Read More

Coronavirus (COVID | 合法醫療器材資訊網

2020年11月17日 — The FDA issued an emergency use authorization for the first COVID-19 diagnostic test that allows for self-collection and testing at home and ... Read More

In Vitro Diagnostics EUAs | 合法醫療器材資訊網

7 天前 — Molecular SARS-CoV-2 Diagnostic Tests for COVID-19 that have been ... With granting of the De Novo for the BioFire RP2.1, the FDA revoked the EUA for this ... 02/03/2021, DiaCarta, Inc, QuantiVirus SARS-CoV-2 Test kit Read More

Notifications and Emergency Use Authorizations | 合法醫療器材資訊網

Q: What in vitro diagnostic tests for COVID-19 have been issued an ... Q: What commercial manufacturers are distributing diagnostic test kits under the policy ... Read More

EUA Authorized Serology Test Performance | 合法醫療器材資訊網

2021年5月25日 — This limits the test's effectiveness for diagnosing current COVID-19 and is one reason ... Test: BioCheck SARS-CoV-2 IgG Antibody Test Kit Read More

Coronavirus (COVID | 合法醫療器材資訊網

2020年12月15日 — The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive ... Read More

Lucira™ COVID-19 All-In | 合法醫療器材資訊網

The Lucira COVID-19 All-In-One Test Kit is a single-use test kit intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19. This test is authorized ... Read More

Taiwan FDA approves imports of COVID | 合法醫療器材資訊網

2021年6月12日 — Taipei, June 12 (CNA) Imports of two types of COVID-19 home test kits to Taiwan have been approved, the Food and Drug Administration ... Read More

COVID home test kits to go on sale in Taiwan next week | 合法醫療器材資訊網

2021年6月19日 — Taipei, June 19 (CNA) COVID-19 home test kits will become available in stores across Taiwan next week, the Food and Drug Administration ... Read More

相關資訊整理

FDA COVID | 合法醫療器材資訊網

Removal Lists of Tests that Should No Longer Be Used andor ... | 合法醫療器材資訊網

COVID | 合法醫療器材資訊網

Coronavirus (COVID | 合法醫療器材資訊網

In Vitro Diagnostics EUAs | 合法醫療器材資訊網

Notifications and Emergency Use Authorizations | 合法醫療器材資訊網

EUA Authorized Serology Test Performance | 合法醫療器材資訊網

Coronavirus (COVID | 合法醫療器材資訊網

Lucira™ COVID-19 All-In | 合法醫療器材資訊網

Taiwan FDA approves imports of COVID | 合法醫療器材資訊網

COVID home test kits to go on sale in Taiwan next week | 合法醫療器材資訊網

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