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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
Buffered sample diluent IVD, manual FDA UDI
Device Name
Serum Diluent Type II FDA UDI
Model / Reference
616139 FDA UDI
Description
Serum Diluent Type II FDA UDI

Identifiers

Primary DI / UDI-DI
05391516746755 FDA UDI
510(k) Number
K914022 FDA UDI
FDA Product Code
LFY FDA UDI
GMDN Term
Buffered sample diluent IVD, manual FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3900 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

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

Dimensions & Sizes

Size
Total Volume — 30 Milliliter FDA UDI

Category: Buffered sample diluent IVD, manual

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

Similar devices

Also classified as Buffered sample diluent IVD, manual.

Cleared under the same submission

K914022 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 ccbafc0a-0c23-430b-a2e9-4253cb9496fd 37 fields · synced May 31, 2026