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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
Angiotensin converting enzyme (ACE) IVD, calibrator FDA UDI
Device Name
ACE Calibrator FDA UDI
Model / Reference
30550 FDA UDI
Description
ACE Calibrator FDA UDI

Identifiers

Catalog Number
30550 FDA UDI
Primary DI / UDI-DI
05391516741545 FDA UDI
510(k) Number
K930477 FDA UDI
FDA Product Code
JIS FDA UDI
GMDN Term
Angiotensin converting enzyme (ACE) IVD, calibrator FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1150 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: Angiotensin converting enzyme (ACE) IVD, calibrator

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

Similar devices

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

Cleared under the same submission

K930477 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 280857b3-c482-4f78-b62f-f3a60a568e67 38 fields · synced May 30, 2026