FDA UDI
In Commercial Distribution
🇺🇸 United States
ImmunoDOT Leptospira IgM
DI: 00613745000046
·
Model: 800-4030
·
GenBio
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- ImmunoDOT Leptospira IgM
- Primary DI
- 00613745000046
- Version / Model
- 800-4030
- Catalog Number
- 4030
- Company Name
- GenBio
- Labeler DUNS
- 940425333
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2026-04-20
- Public Version Status
- Update
- Public Device Record Key
- 16ef00ea-e84b-455a-976a-b9d26e086137
Device Description
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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- Yes
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GRY | Antigens, All, Leptospira Spp. | Microbiology | 866.3350 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 51098 | Multiple Leptospira species immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) | A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to one or multiple species of Leptospira bacteria in a clinical specimen, using an enzyme immunoassay (EIA) method. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00613745000046 | GS1 |
Customer Contacts
- Phone
- 858-592-9300
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K002024 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | 25 tests |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius