BD Veritor™ System for Rapid Detection of Flu A+B CLIA-waived Kit
BD Veritor Flu A+B is a rapid antigen test kit for qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens in nasal or nasopharyngeal swab samples.…
BD Veritor Flu A+B is a rapid antigen test kit for qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens in nasal or nasopharyngeal swab samples. The filed physician configuration contains 30 tests.
The kit is used with the BD Veritor reader system, which interprets the test device’s signal. The test kit and reader have distinct roles in the testing workflow.
Listed Item
Kit Flu A+B 30 Test Physician Veritor
Test and Reader
The test device processes the swab specimen and produces an assay signal, while the Veritor reader supplies the instrument-based readout. The kit is the consumable portion of that system.
This 30-test physician pack is one configuration. The assay target and result format remain the same across the matching Flu A+B test family.
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 | Becton, Dickinson AND Company, 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 | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K112277 |
| Record published | 2017-02-02 |
| Record revised | 2026-03-09 (version 7) |
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 |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 256045 | In distribution | |
| 256041 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K152870 | 2015-10-27 |
| K152874 | 2015-10-27 |
| K151291 | 2015-06-10 |
| K151301 | 2015-06-08 |
| K132693 | 2013-10-02 |
| K132692 | 2013-09-23 |
| K132256 | 2013-08-07 |
| K132259 | 2013-08-07 |
| K121797 | 2012-09-07 |
| K120049 | 2012-03-23 |
| K112277 | 2011-10-28 |
| K101461 | 2010-06-24 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Becton, Dickinson & Co. | 510(k) number | 2022-01-05 | Class II | Under Investigation by firm | May have the potential to overheat and/or cause fire, the issue can occur when an unauthorized alternative AC power adapter, and not the one provided by BD is used to power the instrument. | 126,952 Analyzers Updated:129, 848 Analyzers | |
| Becton, Dickinson & Co. | 510(k) number | 2019-04-03 | Class II | Under Investigation by firm | Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment | 32 units | 2020-05-04 |
| Becton, Dickinson & Co. | 510(k) number | 2019-04-03 | Class II | Under Investigation by firm | Background calibration has the potential to cause false positive or false negative test results. An incorrect test result with the BD Veritor System could lead to possible misdiagnosis and inappropriate treatment | 124 | 2020-05-04 |
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.