BD Veritor™ System CLIA-Waived Combo Pack
BD Veritor™ System CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ System Reader (Cat. No. 256055)
2manufacturers in China registered for this device type
1catalogue number
12510(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 | 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 | 2018-05-25 |
| Record revised | 2023-12-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Distribution end date | 2021-06-28 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 256071 | Withdrawn |
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 |
| 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
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 |
|---|---|---|---|---|---|---|---|
| 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.