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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
Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
CAPTIA™ Syphilis TA EIA FDA UDI
Model / Reference
2322170 FDA UDI
Description
CAPTIA™ Syphilis TA EIA FDA UDI

Identifiers

Catalog Number
2322170 FDA UDI
Primary DI / UDI-DI
05391516745093 FDA UDI
FDA Product Code
LIP FDA UDI
GMDN Term
Treponema pallidum total antibody IVD, kit, enzyme immunoassay (EIA) 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

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: Treponema pallidum total antibody 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 Treponema pallidum total 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 d495f204-52cc-4ad1-b8ea-3ded3c8f45cf 37 fields · synced May 30, 2026