NovaLisa Leptospira IgG
Catalogue number LEPG0660, listed by Gold Standard Diagnostics Frankfurt GmbH, Germany, under Antigens, All, Leptospira Spp. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Genesee Biotech, Inc. | Beijing | Beijing | Manufacturer | 4 |
Record
| Listed by | Gold Standard Diagnostics Frankfurt GmbH, Germany |
|---|---|
| FDA product code | GRY |
| Device type | Antigens, All, Leptospira Spp. |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3350 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-08-26 |
| Record revised | 2024-09-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LEPG0660 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ImmunoDOT Leptospira IgM | Genbio | 3 |
| Leptospira IgG Antibody 96 Test | Scimedx Corp. | 1 |
| AccuDiag ™ | Diagnostic Automation, Inc. | 1 |
| Leptopspira IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 1 |
| Leptospira IgG Elisa | DRG International, Inc. | 1 |
| Leptopspira IgG Elisa | DRG International, Inc. | 1 |
| Leptospira IgG Elisa | DRG Instruments Gesellschaft mit beschränkter Haftung | 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.