← Back to catalogue

Trinity Biotech

FDA UDI

Class I (US FDA UDI)

by Clark Laboratories, Inc.

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Device Name
Captia™ Mumps IgM FDA UDI
Model / Reference
2325960 FDA UDI
Description
Captia™ Mumps IgM FDA UDI

Identifiers

Catalog Number
2325960 FDA UDI
Primary DI / UDI-DI
05391516743624 FDA UDI
FDA Product Code
LJY FDA UDI
GMDN Term
Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
866.3380 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: Mumps virus immunoglobulin M (IgM) 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 Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Clark Laboratories, Inc.

Sources (1)

  • FDA UDI cd52d951-3713-476e-8597-dd3d8b38607c 37 fields · synced Jun 8, 2026