Identity
- Trade Name
- Leptopspira IgG ELISA FDA UDI
- Generic Name
- Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- EIA-4245 FDA UDI
- Description
- 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. FDA UDI
Identifiers
- Catalog Number
- EIA-4245 FDA UDI
- Primary DI / UDI-DI
- 00840239042453 FDA UDI
- FDA Product Code
- GRY FDA UDI
- GMDN Term
- Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3350 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Leptopspira IgG ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Multiple Leptospira species immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- Leptospira IgG Antibody 96 Test — Scimedx Corp. · Class II
- NovaLisa Leptospira IgG — Gold Standard Diagnostics Frankfurt GmbH · Class II
- Leptospira IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Leptopspira IgG ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- Leptospira IgG ELISA — DRG International, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- DRG International, Inc.
Sources (1)
- FDA UDI 5eec9cbe-61fe-4c3c-8b1b-72a5a4e2d457 36 fields · synced May 29, 2026