Identity
- Trade Name
- Sofia FDA UDI
- Generic Name
- Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Sofia2 Lyme WB 25T, US FDA UDI
- Model / Reference
- 20319 FDA UDI
- Description
- Sofia2 Lyme WB 25T, US FDA UDI
Identifiers
- Catalog Number
- 20319 FDA UDI
- Primary DI / UDI-DI
- 30014613337799 FDA UDI
- 510(k) Number
- K173496 FDA UDI
- FDA Product Code
- LSR FDA UDI
- GMDN Term
- Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay 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
No
FDA UDI
Category: Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay
Sofia by Quidel Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Borrelia burgdorferi total antibody IVD, kit, fluorescent immunoassay.
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class II
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class I
- Sofia — Quidel Corp. · 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
- Quidel Corp.
Sources (1)
- FDA UDI 4f5d45e0-416d-4cd5-a873-6d5a90e463a2 37 fields · synced May 30, 2026