Identity
- Trade Name
- Trinity Biotech FDA UDI
- Generic Name
- Multiple Leishmania species total antibody IVD, control FDA UDI
- Device Name
- Leishmania species Positive Control, 250 µL FDA UDI
- Model / Reference
- 20-04002 FDA UDI
- Description
- Leishmania species Positive Control, 250 µL FDA UDI
Identifiers
- Catalog Number
- 20-04002 FDA UDI
- Primary DI / UDI-DI
- 05391516748926 FDA UDI
- FDA Product Code
- LOO FDA UDI
- GMDN Term
- Multiple Leishmania species total antibody IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 866.3870 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
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: Multiple Leishmania species total antibody IVD, control
Trinity Biotech by Mardx Diagnostics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Mardx Diagnostics, Inc.
Sources (1)
- FDA UDI 6ba24fcd-123b-458b-b3a6-68d940fb3338 36 fields · synced Jun 1, 2026