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Trinity Biotech

FDA UDI

Class I (US FDA UDI)

by Clark Laboratories, Inc.

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Captia™ H. pylori IgA FDA UDI
Model / Reference
2326430 FDA UDI
Description
Captia™ H. pylori IgA FDA UDI

Identifiers

Catalog Number
2326430 FDA UDI
Primary DI / UDI-DI
05391516743686 FDA UDI
FDA Product Code
LYR FDA UDI
GMDN Term
Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3110 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

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: Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA)

Trinity Biotech by Clark Laboratories, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Clark Laboratories, Inc.

Sources (1)

  • FDA UDI 94da935d-6718-40b4-b3e7-c32fd4996851 37 fields · synced May 30, 2026