Osom Flu Dipstick 25 Test Kit
Catalogue number 190, listed by Sekisui Diagnostics, LLC, United States, under Antigens, Cf (Including Cf Control), Influenza Virus A, B, C. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
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 | Sekisui Diagnostics, LLC, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-16 |
| Record revised | 2026-06-30 (version 4) |
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 |
| Distribution end date | 2018-01-12 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 190 | 25 | Withdrawn |
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 |
| Status Flu A & B | Princeton BioMeditech Corp. | 1 |
| Henry Schein | Henry Schein, Inc. | 1 |
Showing 12 of 22. All products under Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123182 | 2012-11-05 |
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.