FDA.reportPublic FDA data

T-TAS 01 Total Thrombus Formation Analysis System

Primary DI
04589448510013
Brand
T-TAS 01 Total Thrombus Formation Analysis System
Company
ZACROS CORPORATION
Model
T-TAS 01-1
Catalog number
18001
Device description
System to analyze thrombus formation under blood flow conditions using disposable microchips.
Published
2024-12-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JOZSystem, Automated Platelet Aggregation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOZSystem, Automated Platelet AggregationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191364000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191364000T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01Fujimori Kogyo, Co., Ltd.2020-02-14JOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04589448510020PackageGS11In Commercial Distribution
04589448510013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589448510020045894485100204589448510020
04589448510013045894485100134589448510013

GMDN Terms#

Term, Definition table
TermDefinition
Platelet aggregation analyser IVDAn electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of platelet function in a clinical specimen, by inducing platelet aggregation through the addition of platelet aggregating agents. The instrument may incorporate various technologies including electrical impedance, photometry, turbidimetry and/or luminescence together with sample processing, data processing and/or data display software.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690584370
Device count
1
Serial number
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589448510082PL ChipN/A180022024-12-12
04589448510099PL Chip Reservoir SetN/A180032024-12-12
04589448510105BAPA tubeN/A180042024-12-12
04589448510037PL Chip for T-TAS 01N/A180022024-12-12
04589448510044PL Chip Reservoir Set for T-TAS 01N/A180032024-12-12
04589448510051BAPA tube for T-TAS 01N/A180042024-12-12
14589448510089PL ChipN/A180022024-12-12
14589448510096PL Chip Reservoir SetN/A180032024-12-12
14589448510102BAPA tubeN/A180042024-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589448510082PL ChipZACROS CORPORATIONJOZ2024-12-12
04589448510099PL Chip Reservoir SetZACROS CORPORATIONJOZ2024-12-12
04589448510105BAPA tubeZACROS CORPORATIONJOZ2024-12-12
04589448510037PL Chip for T-TAS 01ZACROS CORPORATIONJOZ2024-12-12
04589448510044PL Chip Reservoir Set for T-TAS 01ZACROS CORPORATIONJOZ2024-12-12
04589448510051BAPA tube for T-TAS 01ZACROS CORPORATIONJOZ2024-12-12
14589448510089PL ChipZACROS CORPORATIONJOZ2024-12-12
14589448510096PL Chip Reservoir SetZACROS CORPORATIONJOZ2024-12-12
14589448510102BAPA tubeZACROS CORPORATIONJOZ2024-12-12
G0561076501AGG/PAK 5 Combo KitBio/Data CorporationJOZ2024-10-01
00811476011045CHRONO-LOGCHRONO-LOG CORPJOZ2023-06-21
00811476011670CHRONO-LOGCHRONO-LOG CORPJOZ2023-06-21
G0561009700AggRecetin Bio/Data CorporationJOZ2022-03-23
G0561012410AggRecetin Bio/Data CorporationJOZ2022-03-23
G0561012971Arachidonic AcidBio/Data CorporationJOZ2022-03-23
G0561013101PAR/PAK IIBio/Data CorporationJOZ2022-03-23
G0561013111EpinephrineBio/Data CorporationJOZ2022-03-23
G0561013121ADPBio/Data CorporationJOZ2022-03-23
G0561015621CollagenBio/Data CorporationJOZ2022-03-23
G0561015801BETA/PakBio/Data CorporationJOZ2022-03-23
10711234500095VerifyNow SystemACCRIVA DIAGNOSTICS HOLDINGS, INC.JOZ2021-04-06
00856893004027AggreguideAGGREDYNE, INC.JOZ2019-09-23
00856893004010AggreDYNE AA AssayAGGREDYNE, INC.JOZ2019-01-01
00856893004065AggreguideAGGREDYNE, INC.JOZ2019-01-01
20856893004014AggreDYNE AA AssayAGGREDYNE, INC.JOZ2019-01-01
00856893004041AggreguideAGGREDYNE, INC.JOZ2019-01-01
10812747018302TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-08-18
30812747018351TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-07-31
10812747018296TEG6s HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-07-17
10812747018340TEG6S HEMOSTASIS SYSTEMHAEMONETICS CORPORATIONJOZ2017-07-17