Premier Adenoclone Type 40/41
Premier Adenoclone-Type 40/41 is an enzyme immunoassay (EIA) for the qualitative detection of enteric adenovirus serotypes 40 and 41 in human fecal specimens.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Minlong Pharmaceutical Biotechnology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 21 |
Record
| Listed by | Meridian Bioscience, Inc., United States |
|---|---|
| FDA product code | GOD |
| Device type | Antigens, Cf (Including Cf Control), Adenovirus 1-33 |
| Device class | Class 1 |
| Regulation | 21 CFR 866.3020 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K881894 |
| Record published | 2020-09-21 |
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 |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 696006 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Adenovirus IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 2 |
| Chorus Adenovirus IgG | Diesse Diagnostica Senese SPA | 1 |
| Rapid Response | Btnx Inc. | 1 |
| InflammaDry | Quidel Corp. | 1 |
| Adenovirus IgG Elisa | DRG International, Inc. | 1 |
| Premier Adenoclone | Meridian Bioscience, Inc. | 1 |
| Quadrox-i | Maquet Cardiopulmonary GmbH | 1 |
| AdenoPlus | Quidel Corp. | 1 |
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.