Identity
- Trade Name
- Lpneu Gr.1 IFA(HT) 180 Test FDA UDI
- Generic Name
- Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay FDA UDI
- Model / Reference
- 7182 FDA UDI
Identifiers
- Catalog Number
- 7182 FDA UDI
- Primary DI / UDI-DI
- 00813545020934 FDA UDI
- 510(k) Number
- K832896 FDA UDI
- FDA Product Code
- LHL FDA UDI
- GMDN Term
- Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay 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
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: Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
Lpneu Gr.1 IFA(HT) 180 Test by Scimedx Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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.
- Trinity Biotech — MARDX DIAGNOSTICS, INC.
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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
- Scimedx Corp.
Sources (1)
- FDA UDI 4d2943a4-6ffa-4b18-b338-320bc5cb3950 35 fields · synced Jun 8, 2026