Status Flu a & B
Status Flu A+B; 5 Test Kit
1manufacturer
1catalogue number
3recalls on this code
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
Record
| Listed by | Princeton BioMeditech Corp., United States |
|---|---|
| FDA product code | GNX |
| Device type | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3330 |
| Establishment | Manufacturer, Exporter |
| Record published | 2017-10-13 |
| Record revised | 2022-06-10 (version 3) |
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 |
| Storage | Storage environment temperature 2 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BSP-510-05-00 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| QuickVue | Quidel Corp. | 3 |
| Status Flu A+B card | Princeton BioMeditech Corp. | 3 |
| BioSign Flu A+B card | Princeton BioMeditech Corp. | 3 |
| Poly stat | Polymedco, Inc. | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | Zhengzhou Shiyi Biotech Co., Ltd. | 2 |
| Sofia | Quidel Corp. | 2 |
| OraSure Quick Flu 22-Count Flu A + B Kit | Orasure Technologies, Inc. | 1 |
| BD Veritor™ Plus Laboratory Combo Pack | Becton, Dickinson AND Company | 1 |
| Status Flu A+B Nasal Wash/Aspirate Kit | Princeton BioMeditech Corp. | 1 |
| Henry Schein | Henry Schein, Inc. | 1 |
| OraSure Quickflu Nasopharyngeal Wash / Aspirate | Orasure Technologies, Inc. | 1 |
Showing 12 of 22. All products under Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2012-03-09 | Class II | Nonconforming Material/Component | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. | 103 kits (22 tests per kit) | 2014-10-14 |
| 2012-03-09 | Class II | Nonconforming Material/Component | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. | 370 (12 tests per kit) ;2800 kits (22 tests per kit) | 2014-10-14 |
| 2012-03-09 | Class II | Nonconforming Material/Component | There have been reports of dual positive (Flu A + Flu B positive) results being encountered. | 90 kits (22 tests per kit) | 2014-10-14 |
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.