The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for…
The GenBio IgM ImmunoDOT Leptospira test is a qualitative enzyme immunoassay that specifically detects IgM antibodies to Leptospira biflexa (serovar patoc 1). This test is presumptive for the laboratory diagnosis of leptospirosis. The IgM ImmunoDOT Test may be used to evaluate a single specimen or paired specimens to detect seroconversion. The test is intended for use in serum, plasma, heparinized whole blood or finger stick capillary blood.
Who Else Makes It
Registered in Beijing.
Record
Regulatory record for ImmunoDOT Leptospira IgM | Listed by | Genbio, United States |
| FDA product code | GRY |
| Device type | Antigens, All, Leptospira Spp. |
| Device class | Class 2 |
| Regulation | 21 CFR 866.3350 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K002024 |
| Record published | 2016-09-24 |
| Record revised | 2026-04-20 (version 4) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
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.