Remel
Xpect Flu A&B KT/20TST
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 | Remel, 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 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K092423 |
| Record published | 2021-11-12 |
| Record revised | 2022-06-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| R24600 | 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 |
| 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 |
Showing 12 of 26. All products under Devices Detecting Influenza A, B, And C Virus Antigens
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K031565 | 2003-07-17 |
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.