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Trinity Biotech

FDA UDI

Class N (US FDA UDI)

by Mardx Diagnostics, Inc.

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Multiple cardiac marker IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Anti Cardiac Antibody IFA Test System, 48 Tests FDA UDI
Model / Reference
10-5448 FDA UDI
Description
Anti Cardiac Antibody IFA Test System, 48 Tests FDA UDI

Identifiers

Catalog Number
10-5448 FDA UDI
Primary DI / UDI-DI
05391516747783 FDA UDI
FDA Product Code
NUK FDA UDI
GMDN Term
Multiple cardiac marker 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: Multiple cardiac marker IVD, kit, fluorescent immunoassay

Trinity Biotech by Mardx Diagnostics, Inc. — Class N — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple cardiac marker IVD, kit, fluorescent immunoassay.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mardx Diagnostics, Inc.

Sources (1)

  • FDA UDI 23562543-cded-4cc3-af55-6dc0b2db3097 36 fields · synced May 30, 2026