Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Legionella longbeachae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- L. pneumophila Slides, Serogroups 1-6, 10 each pack FDA UDI
- Model / Reference
- 30-7102 FDA UDI
- Description
- L. pneumophila Slides, Serogroups 1-6, 10 each pack FDA UDI
Identifiers
- Catalog Number
- 30-7102 FDA UDI
- Primary DI / UDI-DI
- 05391516746366 FDA UDI
- 510(k) Number
- K832896 FDA UDI
- FDA Product Code
- LHL FDA UDI
- GMDN Term
- Legionella longbeachae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3300 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
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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: Legionella longbeachae immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Trinity Biotech by Mardx Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K832896 also covers:
- Trinity Biotech — MARDX DIAGNOSTICS, INC.
- Trinity Biotech — MARDX DIAGNOSTICS, INC.
- Trinity Biotech — MARDX DIAGNOSTICS, INC.
- Trinity Biotech — MARDX DIAGNOSTICS, INC.
- Trinity Biotech — MARDX DIAGNOSTICS, INC.
- Trinity Biotech — MARDX DIAGNOSTICS, INC.
- Trinity Biotech — MARDX DIAGNOSTICS, INC.
- L.pneu 1-6 IFA Poly(HT)180Test — Scimedx Corp.
- L.pneu 1-6 IFA Poly(HT)60 Test — Scimedx Corp.
- L.pneu 1-6(S) 18 Well(HT) — Scimedx Corp.
- L.pneu 1-6(S) 6 Well Slide — Scimedx Corp.
- L.pneu Gr.1(Mono)(HT) 18 Well — Scimedx Corp.
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
- Mardx Diagnostics, Inc.
Sources (1)
- FDA UDI e4c74147-8647-4835-bf01-f4dcf017f2a4 37 fields · synced May 30, 2026