← Back to catalogue

Trinity Biotech

FDA UDI

Class II (US FDA UDI)

by Trinity Biotech Public Limited Company

Identity

Trade Name
Trinity Biotech FDA UDI
Generic Name
Angiotensin converting enzyme (ACE) IVD, reagent FDA UDI
Device Name
ACE Reagent FDA UDI
Model / Reference
305-10 FDA UDI
Description
ACE Reagent FDA UDI

Identifiers

Catalog Number
305-10 FDA UDI
Primary DI / UDI-DI
05391516746014 FDA UDI
510(k) Number
K854245 FDA UDI
FDA Product Code
KQN FDA UDI
GMDN Term
Angiotensin converting enzyme (ACE) IVD, reagent FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1090 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

Category: Angiotensin converting enzyme (ACE) IVD, reagent

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

Similar devices

Also classified as Angiotensin converting enzyme (ACE) IVD, reagent.

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 ce40838d-e744-41bd-8925-fd9ff2755542 38 fields · synced May 30, 2026