510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220039Unknown

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

Ortho-Clinical Diagnostics, Inc., San Diego CA / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN220039 is the FDA 510(k) clearance record for Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set, a class II device, cleared for Quidel Corporation on under FDA product code QVF (Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings). FDA's definition for product code QVF reads: "A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an...". FDA records list 311 510(k) clearances for ORTHO-CLINICAL DIAGNOSTICS, INC., from to . As of , FDA records show no recalls naming DEN220039.

Clearance record

Decision date
Received
(265 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
Quidel Corporation 10165 Mckellar Ct., San Diego CA
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