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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
Skeletal muscle antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
Monkey Skeletal 4 Well Slides, 12 each pack FDA UDI
Model / Reference
10-5804 FDA UDI
Description
Monkey Skeletal 4 Well Slides, 12 each pack FDA UDI

Identifiers

Catalog Number
10-5804 FDA UDI
Primary DI / UDI-DI
05391516748032 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

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: 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

Similar devices

Also classified as Skeletal muscle antibody 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 08271a56-ae82-42ae-8090-8364e4990c84 36 fields · synced May 30, 2026