TriniCAL™ Fibrinogen

FDA UDI

Class II (US FDA UDI)

by Tcoag Ireland Limited

Identity

Trade Name: TriniCAL™ Fibrinogen FDA UDI
Generic Name: Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI
Model / Reference: T5104 FDA UDI

Identifiers

Primary DI / UDI-DI: 15391521420722 FDA UDI
510(k) Number: K971858 FDA UDI
FDA Product Code: KQJ FDA UDI
GMDN Term: Fibrinogen assay (factor I) IVD, kit, clotting FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7340 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Fibrinogen assay (factor I) IVD, kit, clotting

TriniCAL™ Fibrinogen by Tcoag Ireland Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Fibrinogen assay (factor I) IVD, kit, clotting.

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Dade Fibrinogen Determination Reagents — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Fibrinogen Assay Kit — Helena Laboratories, Corp. · Class II
Fibrotek — R2 DIAGNOSTICS, INC. · Class II
Diazyme — Diazyme Laboratories, Inc.
N Antiserum to Human Fibrinogen — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Dade® Fibrinogen Determination Reagents — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
TriniCLOT™ Thrombin Time 4ml — TCOAG IRELAND LIMITED · Class II

Cleared under the same submission

K971858 also covers:

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 II	Pending data

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Manufacturer

Manufacturer: Tcoag Ireland Limited

Sources (1)

FDA UDI adf0b922-2843-4318-a199-6227a94a24de 34 fields · synced May 30, 2026