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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 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay FDA UDI
Device Name
T. Pallidum IgG Marblot Strip Test System, Western Blot System for the detection of IgG antibody to T. pallidum, 20 Tests FDA UDI
Model / Reference
40-5020G FDA UDI
Description
T. Pallidum IgG Marblot Strip Test System, Western Blot System for the detection of IgG antibody to T. pallidum, 20 Tests FDA UDI

Identifiers

Catalog Number
40-5020G FDA UDI
Primary DI / UDI-DI
05391516748704 FDA UDI
FDA Product Code
JWL FDA UDI
GMDN Term
Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay 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 immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

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 immunoglobulin G (IgG) 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 21d8ec12-ebc0-40a0-9332-f477bea47220 36 fields · synced May 30, 2026