QuickVue COVID-19 Test
K-Number: K231795 · 2024-03-22
ApplicantQuidel Corporation
Decision Date2024-03-22
Product CodeQYT
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
QuickVue COVID-19 Test is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2024-03-22 under approval number K231795. The device is classified under product code QYT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the QuickVue COVID-19 Test?
QuickVue COVID-19 Test is a medical device that received FDA 510(k) clearance on 2024-03-22. It is manufactured by Quidel Corporation. The 510(k) number is K231795.
When was QuickVue COVID-19 Test approved by the FDA?
QuickVue COVID-19 Test received FDA 510(k) clearance on 2024-03-22, under approval number K231795.
What company makes QuickVue COVID-19 Test?
QuickVue COVID-19 Test is manufactured by Quidel Corporation.
What is the FDA product code for QuickVue COVID-19 Test?
The FDA product code for QuickVue COVID-19 Test is QYT.
Other Devices by Quidel Corporation
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K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestCorDx, Inc.
K233842iHealth COVID-19 Antigen Rapid TestIhealth Labs, Inc.
K233373Flowflex® Plus COVID-19 Home TestACON Laboratories, Inc.
K251595COVID-19 Detect Rapid Self -TestInBios International, Inc.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.