FLU/RSV Positive Control
FLU/RSV Positive Control is an external control reagent to be used with TRU FLU and TRU RSV Test Kits as part of a routine quality control program
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), elsewhere (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Orient Gene Biotech | Huzhou | Zhejiang | Contract manufacturer | 86 |
| Hangzhou Clongene Biotech Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 21 |
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 21 |
| BD Rapid Diagnostics (Suzhou) Co., Ltd. | China (Jiangsu) Pilot Free Trade Zone Suzhou Area | Manufacturer | 6 |
Record
| Listed by | Meridian Bioscience, Inc., United States |
|---|---|
| FDA product code | GQG |
| Device type | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3480 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K071101 |
| Record published | 2020-11-17 |
| Record revised | 2021-06-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2021-05-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 751110 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BinaxNOW RSV | Alere Scarborough, Inc. | 4 |
| RDS | American Bio Medica Corp. | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 2 |
| Sofia | Quidel Corp. | 2 |
| Rapid Response | Btnx Inc. | 2 |
| Chorus Respiratory Syncytial Virus IgG | Diesse Diagnostica Senese SPA | 1 |
| Red Tunica | Rodimedi & Associates Inc. | 1 |
| TRU RSV | Meridian Bioscience, Inc. | 1 |
| Nano-Check RSV Test | Nano-Ditech Corporation | 1 |
| Osom RSV Test | Sekisui Diagnostics, LLC | 1 |
| Ramp® RSV Test KIT; 25 Tests | Response Biomedical Corp. | 1 |
| Ramp® RSV Control Swabs | Response Biomedical Corp. | 1 |
Showing 12 of 20. All products under Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K041445 | 2004-08-13 |
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.