Who else makes this device?

Name: T-TAS 01 Total Thrombus Formation Analysis System
Brand: T-TAS 01 Total Thrombus Formation Analysis System

Hematology › Automated Hematology DevicesSystem, Automated Platelet Aggregation

T-TAS 01 Total Thrombus Formation Analysis System

System to analyze thrombus formation under blood flow conditions using disposable microchips.

Registry build 21.09.26

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code JOZ
Manufacturer	City	Province	Registered as	Device types
Zhejiang Gongdong Medical Technology Co., Ltd.	Taizhou	Zhejiang	Contract manufacturer	40

Record

Regulatory record for T-TAS 01 Total Thrombus Formation Analysis System
Listed by	Zacros Corporation, Japan
FDA product code	JOZ
Device type	System, Automated Platelet Aggregation
Device class	Class 2
Regulation	21 CFR 864.5700
Establishment	Specification developer, Complaint-file establishment, Manufacturer, Exporter
510(k)	K191364
Record published	2024-12-06

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	serial number

Catalogue Numbers

Catalogue numbers for T-TAS 01 Total Thrombus Formation Analysis System
Catalogue number	Size	Status
T-TAS 01-1		In distribution

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AggRecetin	Bio/Data Corp.	2
Aggreguide	Aggredyne, Inc.	2
Plateletworks Combo-25 Kit	Helena Laboratories, Corp.	1
Epinephrine	Bio/Data Corp.	1
Bapa tube	Zacros Corporation	1
PL Chip for T-TAS 01	Zacros Corporation	1

Showing 12 of 34. All products under System, Automated Platelet Aggregation

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.