Sofia
Sofia Flu A+B 25T
1manufacturer
2catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
Record
| Listed by | Quidel Corp., United States |
|---|---|
| FDA product code | GNX |
| Device type | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3330 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K112177 |
| Record published | 2018-11-10 |
| Record revised | 2025-11-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 20254 | In distribution | |
| 20218 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QuickVue | Quidel Corp. | 3 |
| Status Flu A+B card | Princeton BioMeditech Corp. | 3 |
| BioSign Flu A+B card | Princeton BioMeditech Corp. | 3 |
| Poly stat | Polymedco, Inc. | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | Zhengzhou Shiyi Biotech Co., Ltd. | 2 |
| OraSure Quick Flu 22-Count Flu A + B Kit | Orasure Technologies, Inc. | 1 |
| BD Veritor™ Plus Laboratory Combo Pack | Becton, Dickinson AND Company | 1 |
| Status Flu A+B Nasal Wash/Aspirate Kit | Princeton BioMeditech Corp. | 1 |
| Status Flu A & B | Princeton BioMeditech Corp. | 1 |
| Henry Schein | Henry Schein, Inc. | 1 |
| OraSure Quickflu Nasopharyngeal Wash / Aspirate | Orasure Technologies, Inc. | 1 |
Showing 12 of 22. All products under Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131599 | 2013-07-05 |
| K131606 | 2013-07-05 |
| K131619 | 2013-06-28 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Quidel Corp. | 510(k) number | 2012-12-03 | Class II | Nonconforming Material/Component | Quidel Corporation has initiated a voluntary recall of specific lots of the Sofia Influenza A+B FIA kits because of false positive results which may lead to misdiagnosis. | 13,090 kits (327,250 tests) | 2014-01-31 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.