Simplexa™ Influenza a H1N1 (2009)
Catalogue number MOL2500, listed by DiaSorin Molecular LLC, United States, under 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hochuen Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 20 |
Record
| Listed by | DiaSorin Molecular LLC, United States |
|---|---|
| FDA product code | OQW |
| Device type | 2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3332 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Record published | 2016-09-22 |
| Record revised | 2024-07-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -30 to -10 °C |
| Distribution end date | 2024-07-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MOL2500 | Withdrawn |
Same Product Code
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.