Identity
- Trade Name
- Borrelia burgdorferi IgM (Lyme) ELISA FDA UDI
- Generic Name
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The Borrelia burgdorferi IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibody to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease. FDA UDI
- Model / Reference
- EIA-2811 FDA UDI
- Description
- The Borrelia burgdorferi IgM ELISA test system is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgM class antibody to Borrelia burgdorferi in human serum. This assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme disease. FDA UDI
Identifiers
- Catalog Number
- EIA-2811 FDA UDI
- Primary DI / UDI-DI
- 00840239028112 FDA UDI
- 510(k) Number
- K900196 FDA UDI
- FDA Product Code
- LSR FDA UDI
- GMDN Term
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3830 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Borrelia burgdorferi IgM (Lyme) ELISA by DRG International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA).
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- MarDx — CLARK LABORATORIES, INC. · Class II
- ELISA B. burgdorferi IgG/IgM Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
- B. burgdorferi IgG/IgM ELISA — DRG Instruments Gesellschaft mit beschränkter Haftung · Class II
- ELISA Borrelia VlsE1/pepC10 IgG/IgM Smart Kit Test System — ZEUS SCIENTIFIC, INC.
Cleared under the same submission
K900196 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- DRG International, Inc.
Sources (1)
- FDA UDI 3d294851-74cf-484a-8bd0-24da03668450 37 fields · synced May 30, 2026