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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, reagent FDA UDI
Device Name
Oxalate Sample Diluent FDA UDI
Model / Reference
591-4-1000 FDA UDI
Description
Oxalate Sample Diluent FDA UDI

Identifiers

Catalog Number
591-4-1000 FDA UDI
Primary DI / UDI-DI
05391516749640 FDA UDI
510(k) Number
K883525 FDA UDI
FDA Product Code
LPW FDA UDI
GMDN Term
Oxalate IVD, reagent 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

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 — 1000 Milliliter FDA UDI

Category: Oxalate IVD, reagent

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, reagent.

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 94821eea-60d9-4662-84e5-5ebd1ee6162e 38 fields · synced May 31, 2026