510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K254264Substantially Equivalent

Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho), San Diego CA / Dual Track, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(248 days to decision)
Product code
QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Regulation
21 CFR 866.3982
Device class
Class II
Review panel
Microbiology
Applicant
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) 9975 Summers Ridge Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QVF

Trailing 12 months
2 clearances under product code QVF in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code QVF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20261
October 20260