Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set— 510(k) DEN220039

Name: FDA 510(k) clearance DEN220039
Creator: U.S. Food and Drug Administration
Published: 2023-03-08

Unknown

Quidel Corporation

FDA 510(k) clearance DEN220039 for Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set, Unknown on 2023-03-08. Applicant: Quidel Corporation. Device class: 2.

Clearance details

Applicant: Quidel Corporation
Product code: Code QVF
Device class: Class 2
Regulation: 21 CFR 866.3982
Advisory panel: Microbiology
Date received: 2022-06-16
Decision date: 2023-03-08
Decision: Unknown
Clearance type: Post-NSE
Location: San Diego, CA, US

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.