Leptopspira IgG Elisa
The Leptospira IgG ELISA test is an enzyme immunoassay for the detection of antibodies to Leptospira biflexa (serovar patoc 1) for the serological confirmation of infections in serum and…
The Leptospira IgG ELISA test is an enzyme immunoassay for the detection of antibodies to Leptospira biflexa (serovar patoc 1) for the serological confirmation of infections in serum and plasma.
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 | DRG International, Inc., United States |
|---|---|
| FDA product code | GRY |
| Device type | Antigens, All, Leptospira Spp. |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3350 |
| Establishment | Repacker / relabeller, Complaint-file establishment |
| Premarket notification | Exempt |
| Record published | 2019-06-05 |
| Record revised | 2020-03-30 (version 2) |
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 |
|---|---|---|
| EIA-4245 | 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 |
| NovaLisa Leptospira IgG | Gold Standard Diagnostics Frankfurt GmbH | 1 |
| Leptospira 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.