510(k) clearances

Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA

Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) · Microbiology

K254264Substantially EquivalentDual TrackQVF
Open FDA's page for this record
Third party flag
N
City
San Diego
Advisory committee description
Microbiology
Address 1
9975 Summers Ridge Rd.
Statement or summary
Summary
Product code
QVF
Zip code
92121
Applicant
Ortho-Clinical Diagnostics, Inc. (QuidelOrtho)
Decision date
2026-09-04
Decision code
SESE
Country code
US
Device name
Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA
Advisory committee
MI
Contact
Xiaoxi Wang
K number
K254264
State
CA
Date received
2025-12-30
Review advisory committee
MI
Postal code
92121
Decision description
Substantially Equivalent
Clearance type
Dual Track
Harmonized identifiers (openFDA)
Device name
Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
Medical specialty description
Microbiology
Regulation number
866.3982
Device class
2
Registration number
3023322455, 3008517993, 3004635103, 3018786392, 3009238284, 3026664926, 2030538, 3007886372, 3005174594, 3032562, 3002792284, 2024674, 3033507883, 3033751096, 3007606081, 3006948883, 1119779, 3021090658, 3031823359, 3034405508
FEI number
3023322455, 3008517993, 3004635103, 3018786392, 3009238284, 3026664926, 3007886372, 3005174594, 3002792284, 2024674, 3033507883, 3033751096, 3007606081, 3006948883, 1119779, 3021090658, 3031823359, 3002606748, 1000520007, 3034405508
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.