TriniCHECK Level 1

FDA UDI

Class I (US FDA UDI)

by Tcoag Ireland Limited

Identity

Trade Name: TriniCHECK Level 1 FDA UDI
Generic Name: Multiple coagulation factor IVD, control FDA UDI
Model / Reference: T4111 FDA UDI

Identifiers

Primary DI / UDI-DI: 15391521420630 FDA UDI
FDA Product Code: OHQ FDA UDI
GMDN Term: Multiple coagulation factor IVD, control FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 862.1660 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Multiple coagulation factor IVD, control

TriniCHECK Level 1 by Tcoag Ireland Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Thermo Scientific Pacific Hemostasis® — Fisher Diagnostics · Class II
CRYOcheck™ Abnormal 1 Reference Control — Precision Biologic · Class II
JAS Diagnostics — Drew Scientific , Ltd.
CueSee® Coag — Eurotrol B.V. · Class II
COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1) — Randox Laboratories, Ltd. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Tcoag Ireland Limited

Sources (1)

FDA UDI 7bc2de39-fe52-49bd-b0be-9487b900cedd 33 fields · synced Jun 8, 2026