TriniCHECK™ Lupus Positive Control

FDA UDI

Class II (US FDA UDI)

by Tcoag Ireland Limited

Identity

Trade Name: TriniCHECK™ Lupus Positive Control FDA UDI
Generic Name: Lupus anticoagulant marker IVD, kit, clotting FDA UDI
Model / Reference: T4203 FDA UDI

Identifiers

Primary DI / UDI-DI: 15391521420661 FDA UDI
510(k) Number: K961370 FDA UDI
FDA Product Code: GGC FDA UDI
GMDN Term: Lupus anticoagulant marker IVD, kit, clotting FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5425 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: Lupus anticoagulant marker IVD, kit, clotting

TriniCHECK™ Lupus Positive Control by Tcoag Ireland Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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CRYOcheck Hex LA — Precision Biologic · Class II
DVVconfirm 5 — Biomedica ADI Inc. · Class I
STA® - Staclot® dRVV Confirm — DIAGNOSTICA STAGO, INC. · Class I
LupoTek Detectin VL — R2 DIAGNOSTICS, INC. · 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 II	Pending data

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Manufacturer

Manufacturer: Tcoag Ireland Limited

Sources (1)

FDA UDI 64e491d6-eeaa-497c-b4c6-c2ba2ea3cea0 34 fields · synced May 30, 2026