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Trinity Biotech

FDA UDI

Class I (US FDA UDI)

by Trinity Biotech Public Limited Company

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Oxalate IVD, calibrator FDA UDI
Device Name
Oxalate Standards FDA UDI
Model / Reference
591-11 FDA UDI
Description
Oxalate Standards FDA UDI

Identifiers

Catalog Number
591-11 FDA UDI
Primary DI / UDI-DI
05391516742184 FDA UDI
510(k) Number
K883525 FDA UDI
FDA Product Code
LPW FDA UDI
GMDN Term
Oxalate IVD, calibrator FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1542 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: Oxalate IVD, calibrator

Trinity Biotech by Trinity Biotech Public Limited Company — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Oxalate IVD, calibrator.

Cleared under the same submission

K883525 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Trinity Biotech Public Limited Company

Sources (1)

  • FDA UDI c56ab5fa-d12a-411c-a530-8a265352051e 38 fields · synced May 30, 2026