Fluoro-CheckTM Influenza A+B
An in vitro diagnostic test for the detection of influenza A and influenza B viral nucleoprotein antigens from nasopharyngeal secretion specimens in symptomatic patients.
2manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in elsewhere (1), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 | |
| Innovita (Tangshan) Biological Technology Co., Ltd. | Qian’An | Hebei | Manufacturer | 5 |
Record
| Listed by | Nano-Ditech Corporation, United States |
|---|---|
| FDA product code | PSZ |
| Device type | Devices Detecting Influenza A, B, And C Virus Antigens |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3328 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2019-05-24 |
| Record revised | 2023-06-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| TF8147 | 20 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BD Veritor™ System For Rapid Detection of Flu A+B CLIA-waived kit | Becton, Dickinson AND Company | 2 |
| Acucy Flu Test Kit | Sekisui Diagnostics, LLC | 1 |
| Acucy System | Sekisui Diagnostics, LLC | 1 |
| ImmunoCard Stat! FLU A&B | Meridian Bioscience, Inc. | 1 |
| Alere BinaxNOW Influenza A & B Card 2 | Alere Scarborough, Inc. | 1 |
| Osom Ultra Plus FLU A&B Test | Sekisui Diagnostics, LLC | 1 |
| BD Veritor™ System CLIA-Waived Combo Pack | Becton, Dickinson AND Company | 1 |
| ID NOW Influenza A & B 2 | Alere Scarborough, Inc. | 1 |
| Acucy System Universal Drawer | Sekisui Diagnostics, LLC | 1 |
| Osom Ultra Plus FLU A&B Control Kit | Sekisui Diagnostics, LLC | 1 |
| BinaxNOW Influenza A & B Card 2 | Alere Scarborough, Inc. | 1 |
| Acucy Calibration Device | Sekisui Diagnostics, LLC | 1 |
Showing 12 of 26. All products under Devices Detecting Influenza A, B, And C Virus Antigens
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252283 | 2026-01-15 |
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.