FDA Product Code
FDA Product Code QVF — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Microbiology
- 21 CFR Citation
- 866.3982
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIA | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 2026-09-04 | Dual Track | PDF ↗ |
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test Rx | CorDx, Inc. | 2026-06-01 | Dual Track | PDF ↗ |
| K251289 | WELLlife COVID-19 Antigen Test Rx | Guangzhou Wondfo Biotech Co., Ltd. | 2025-10-22 | Dual Track | PDF ↗ |
| K243872 | BD Veritor System for SARS-CoV-2 | Becton, Dickinson and Company | 2025-06-16 | Dual Track | PDF ↗ |
| K250273 | BinaxNOW COVID-19 Ag Card | Abbott Diagnostics Scarborough, Inc. | 2025-06-13 | Dual Track | PDF ↗ |
| K233358 | SCoV-2 Ag Detect Rapid Test | InBios International, Inc. | 2024-08-23 | Dual Track | PDF ↗ |
| K232377 | Healgen Rapid COVID-19 Antigen Test | Healgen Scientific,, LLC | 2024-04-19 | Traditional | PDF ↗ |
| K231187 | Nano-Check COVID-19 Antigen Test | Nano-Ditech Corporation | 2024-01-23 | Traditional | PDF ↗ |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | 2023-12-13 | Special | PDF ↗ |
| DEN220039 | Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set | Quidel Corporation | 2023-03-08 | Post-NSE | — |
Product code QVF · Class II · Microbiology. Data: openFDA.