Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Skeletal muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- Anti Skeletal Antibody IFA Test System, 48 Tests FDA UDI
- Model / Reference
- 10-5848 FDA UDI
- Description
- Anti Skeletal Antibody IFA Test System, 48 Tests FDA UDI
Identifiers
- Catalog Number
- 10-5848 FDA UDI
- Primary DI / UDI-DI
- 05391516748025 FDA UDI
- FDA Product Code
- NUL FDA UDI
- GMDN Term
- Skeletal muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- N 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Skeletal muscle antibody IVD, kit, fluorescent immunoassay
Trinity Biotech by Mardx Diagnostics, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Skeletal muscle antibody IVD, kit, fluorescent immunoassay.
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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 N | Pending data |
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Manufacturer
- Manufacturer
- Mardx Diagnostics, Inc.
Sources (1)
- FDA UDI 2dccc4dc-6635-4980-887c-65c5f2cb691c 36 fields · synced Jun 8, 2026