← Back to catalogue

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, kit, spectrophotometry FDA UDI
Device Name
Oxalate Kit FDA UDI
Model / Reference
591-C FDA UDI
Description
Oxalate Kit FDA UDI

Identifiers

Catalog Number
591-C FDA UDI
Primary DI / UDI-DI
05391516742238 FDA UDI
510(k) Number
K883525 FDA UDI
FDA Product Code
LPW FDA UDI
GMDN Term
Oxalate IVD, kit, spectrophotometry 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, kit, spectrophotometry

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, kit, spectrophotometry.

Cleared under the same submission

K883525 also covers:

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
Trinity Biotech Public Limited Company

Sources (1)

  • FDA UDI b307a2b3-823e-4337-8805-e8725dec16f1 38 fields · synced May 30, 2026