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Trinity Biotech

FDA UDI

Class II (US FDA UDI)

by Mardx Diagnostics, Inc.

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Treponema pallidum antigen IVD, control FDA UDI
Device Name
Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Control, 1 Positive Control and 1 Negative Control FDA UDI
Model / Reference
1206711 FDA UDI
Description
Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Control, 1 Positive Control and 1 Negative Control FDA UDI

Identifiers

Catalog Number
1206711 FDA UDI
Primary DI / UDI-DI
05391516748766 FDA UDI
FDA Product Code
LIP FDA UDI
GMDN Term
Treponema pallidum antigen IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3830 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: Treponema pallidum antigen IVD, control

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

Similar devices

Also classified as Treponema pallidum antigen IVD, control.

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 bc679fb2-3d8b-4514-bdcd-e7ce338e60d2 36 fields · synced Jun 1, 2026