Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Phosphate Buffered Saline, 10g FDA UDI
- Model / Reference
- 90-1607 FDA UDI
- Description
- Phosphate Buffered Saline, 10g FDA UDI
Identifiers
- Catalog Number
- 90-1607 FDA UDI
- Primary DI / UDI-DI
- 05391516747585 FDA UDI
- FDA Product Code
- MVJ FDA UDINUK FDA UDILSR FDA UDIMIV FDA UDINUL FDA UDILOO FDA UDILHL FDA UDI
- GMDN Term
- Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI866.3830 FDA UDI866.3870 FDA UDI866.3300 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Legionella pneumophila total antibody IVD, kit, fluorescent immunoassayBorrelia burgdorferi total antibody IVD, kit, immunoblotMultiple cardiac marker IVD, kit, fluorescent immunoassaySkeletal muscle antibody IVD, kit, fluorescent immunoassay
Trinity Biotech by Mardx Diagnostics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Trypanosoma cruzi immunoglobulin G (IgG)/IgM antibody IVD, kit, fluorescent immunoassay.
- Trinity Biotech — MARDX DIAGNOSTICS, INC. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Mardx Diagnostics, Inc.
Sources (1)
- FDA UDI 8f377809-a46e-4844-ab4f-417e3eaf45d7 36 fields · synced May 30, 2026