Panels › Microbiology › Product code SCA · Class 2
Multi-Analyte Respiratory Virus Antigen Detection Test
Regulation 866.3987
5510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in SCA
| Company | 510(k)s | Recalls |
|---|---|---|
| ACON Laboratories, Inc. | 3 | 0 |
| Ihealth Labs, Inc. | 2 | 0 |
| Wondfo USA Co, Ltd. | 2 | 0 |
| Access Bio, Inc. | 1 | 0 |
| CorDx, Inc. | 1 | 0 |
| Healgen | 1 | 0 |
| Nano-Ditech Corporation | 1 | 0 |
| Osang, LLC | 1 | 0 |
| Princeton BioMeditech Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 14, 2026 | K262432 | CorDx Tyfast Flu A/B & COVID-19 At Home Multiplex Rapid Test; CorDx Tyfast Flu A/B & COVID-19 Multiplex Rapid Test CorDx, Inc. | SCA |
| Jul 10, 2026 | K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test ACON Laboratories, Inc. | SCA |
| Dec 12, 2025 | K251092 | iHealth Flu A&B/COVID-19 Rapid Test; iHealth Flu A&B/COVID-19 Rapid Test Pro Ihealth Labs, Inc. | SCA |
| Dec 12, 2025 | K251085 | iHealth Flu A&B/COVID-19/RSV Rapid Test; iHealth Flu A&B/COVID-19/RSV Rapid Test Pro Ihealth Labs, Inc. | SCA |
| Nov 14, 2025 | K251538 | Status COVID-19/Flu A&B Princeton BioMeditech Corp. | SCA |
| Oct 22, 2025 | K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test ACON Laboratories, Inc. | SCA |
| Aug 22, 2025 | K251604 | CareSuperb COVID-19/Flu A&B Antigen Combo Home Test Access Bio, Inc. | SCA |
| Aug 20, 2025 | K251563 | WELLlife Flu A&B Home Test; WELLlife Influenza A&B Test Wondfo USA Co, Ltd. | SCA |
| Jun 17, 2025 | K243561 | Nano-Check Influenza+COVID-19 Dual Test Nano-Ditech Corporation | SCA |
| May 10, 2025 | K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test ACON Laboratories, Inc. | SCA |
| Jan 16, 2025 | K243256 | WELLlife COVID-19 / Influenza A&B Home Test; WELLlife COVID-19 / Influenza A&B AntigenTest Wondfo USA Co, Ltd. | SCA |
| Jan 13, 2025 | K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test Osang, LLC | SCA |
| Oct 7, 2024 | DEN240029 | Healgen Rapid Check COVID-19/Flu A&B Antigen Test Healgen | SCA |
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