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FDA 510(k)

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set

K-Number: K233688 · 2023-12-13

ApplicantQuidel Corporation
Decision Date2023-12-13
Product CodeQVF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set is a medical device manufactured by Quidel Corporation. It received FDA 510(k) clearance on 2023-12-13 under approval number K233688. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set?

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Quidel Corporation. The 510(k) number is K233688.

When was Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set approved by the FDA?

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set received FDA 510(k) clearance on 2023-12-13, under approval number K233688.

What company makes Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set?

Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set is manufactured by Quidel Corporation.

What is the FDA product code for Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set?

The FDA product code for Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set is QVF.

Related Clinical Trials

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Related Devices (Code: QVF)

DEN220039Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab SetQuidel Corporation K233358SCoV-2 Ag Detect Rapid TestInBios International, Inc. K232377Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLC K231187Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation K251289WELLlife COVID-19 Antigen Test RxGuangzhou Wondfo Biotech Co., Ltd. K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and Company

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.

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