TriniCHROM™ Antithrombin Xa

FDA UDI

Class II (US FDA UDI)

by Tcoag Ireland Limited

Identity

Trade Name: TriniCHROM™ Antithrombin Xa FDA UDI
Generic Name: Antithrombin III (ATIII) IVD, kit, chromogenic FDA UDI
Model / Reference: T2603 FDA UDI

Identifiers

Primary DI / UDI-DI: 05391521420541 FDA UDI
510(k) Number: K960871 FDA UDI
FDA Product Code: JBQ FDA UDI
GMDN Term: Antithrombin III (ATIII) IVD, kit, chromogenic FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.7060 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: Antithrombin III (ATIII) IVD, kit, chromogenic

TriniCHROM™ Antithrombin Xa by Tcoag Ireland Limited — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Antithrombin III (ATIII) IVD, kit, chromogenic.

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STA® - Stachrom® AT III 3 — DIAGNOSTICA STAGO, INC. · Class II
INNOVANCE® Antithrombin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
ACTICHROME ATIII KIT — Biomedica ADI Inc. · Class II
Berichrom Antithrombin III (A) — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
INNOVANCE Antithrombin — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II

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 2552a8d0-2f0f-4d10-955d-9c0b572095cc 34 fields · synced May 30, 2026