Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Borrelia burgdorferi immunoglobulin G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Captia Borrelia burgdorferi IgG/IgM FDA UDI
- Model / Reference
- 2346581 FDA UDI
- Description
- Captia Borrelia burgdorferi IgG/IgM FDA UDI
Identifiers
- Catalog Number
- 2346581 FDA UDI
- Primary DI / UDI-DI
- 05391516747486 FDA UDI
- 510(k) Number
- K033083 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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 G (IgG)/IgM antibody IVD, kit, enzyme immunoassay (EIA)
Trinity Biotech by Clark Laboratories, 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
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- 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.
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
Cleared under the same submission
K033083 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
- Clark Laboratories, Inc.
Sources (1)
- FDA UDI b4e1e40c-099c-4bd7-8b53-d7a12166f24e 38 fields · synced Jun 8, 2026