Identity
- Trade Name
- VIDAS® Lyme IgM II FDA UDI
- Generic Name
- Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- VIDAS Lyme IgM II assay is an automated qualitative enzyme immunoassay intended for use on VIDAS family instrument for detection of human IgM antibodies to Borrelia burgdorferi. FDA UDI
- Model / Reference
- 416436 FDA UDI
- Description
- VIDAS Lyme IgM II assay is an automated qualitative enzyme immunoassay intended for use on VIDAS family instrument for detection of human IgM antibodies to Borrelia burgdorferi. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026447151 FDA UDI
- 510(k) Number
- K122979 FDA UDI
- FDA Product Code
- LSR FDA UDI
- GMDN Term
- Borrelia burgdorferi immunoglobulin M (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
No
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
No
FDA UDI
Category: Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
VIDAS® Lyme IgM II by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Anti-Borrelia burgdorferi US EUROLINE-WB (IgM) — EUROIMMUN Medizinische Labordiagnostika AG · Class II
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- MarDx — CLARK LABORATORIES, 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
- Biomerieux , Inc.
Sources (1)
- FDA UDI ab465312-4012-4bc7-960d-c47c1ba52bf1 35 fields · synced Jun 8, 2026