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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
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, reagent FDA UDI
Device Name
Alkaline Phosphatase Conjugate, Anti-Human IgM, 11 mL FDA UDI
Model / Reference
40-2525M FDA UDI
Description
Alkaline Phosphatase Conjugate, Anti-Human IgM, 11 mL FDA UDI

Identifiers

Catalog Number
40-2525M FDA UDI
Primary DI / UDI-DI
05391516747691 FDA UDI
510(k) Number
K951709 FDA UDI
FDA Product Code
LSR FDA UDI
GMDN Term
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, reagent 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

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, reagent

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

Cleared under the same submission

K951709 also covers:

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 1654e54c-3b36-4165-856c-c00b25d1ce3f 37 fields · synced May 30, 2026