ID NOW Influenza a & B 2
A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimens.
2manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
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 | Alere Scarborough, Inc., 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 |
| Record published | 2018-10-29 |
| Record revised | 2023-09-12 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 427-000 | 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 |
| Fluoro-CheckTM Influenza A+B | Nano-Ditech Corporation | 1 |
| 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 |
| 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 |
|---|---|
| K181853 | 2018-08-08 |
| K173502 | 2017-12-13 |
| K162642 | 2017-04-10 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Abbott Diagnostics Scarborough, Inc. | UDI-DI | 2026-02-09 | Class II | Under Investigation by firm | It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use. | 111984 units |
| Abbott Diagnostics Scarborough, Inc. | UDI-DI | 2025-03-04 | Class II | Process change control | The impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | 592320 eaches (535416 US, 56904 OUS) |
| Abbott Diagnostics Scarborough, Inc. | UDI-DI | 2025-03-04 | Class II | Process change control | the impacted lots have a higher occurrence of invalid rates when compared to the product Instructions for Use. | 2,776,416 eaches |
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.