T-TAS 01 Total Thrombus Formation Analysis System

FDA UDI

Class II (US FDA UDI)

by Zacros Corporation

Identity

Trade Name: T-TAS 01 Total Thrombus Formation Analysis System FDA UDI
Generic Name: Platelet aggregation analyser IVD FDA UDI
Device Name: System to analyze thrombus formation under blood flow conditions using disposable microchips. FDA UDI
Model / Reference: T-TAS 01-1 FDA UDI
Description: System to analyze thrombus formation under blood flow conditions using disposable microchips. FDA UDI

Identifiers

Catalog Number: 18001 FDA UDI
Primary DI / UDI-DI: 04589448510013 FDA UDI
510(k) Number: K191364 FDA UDI
FDA Product Code: JOZ FDA UDI
GMDN Term: Platelet aggregation analyser IVD FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5700 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

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Platelet aggregation analyser IVD

T-TAS 01 Total Thrombus Formation Analysis System by Zacros Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K191364 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: Zacros Corporation

Sources (1)

FDA UDI 9f738a6b-c643-4567-89af-2c03968b9624 35 fields · synced Jun 1, 2026