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Trinity Biotech

FDA UDI

Class II (US FDA UDI)

by Clark Laboratories, Inc.

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Captia™ ENA Combined Screen FDA UDI
Model / Reference
2338571 FDA UDI
Description
Captia™ ENA Combined Screen FDA UDI

Identifiers

Catalog Number
2338571 FDA UDI
Primary DI / UDI-DI
05391516747172 FDA UDI
510(k) Number
K935413 FDA UDI
FDA Product Code
LLL FDA UDI
GMDN Term
Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.5100 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: Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA)

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

Similar devices

Also classified as Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, enzyme immunoassay (EIA).

Cleared under the same submission

K935413 also covers:

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 260cd255-2757-49f7-8905-6b0c7806f582 38 fields · synced May 30, 2026