FDA.reportPublic FDA data

AggreDYNE AA Assay

Primary DI
00856893004010
Brand
AggreDYNE AA Assay
Company
AGGREDYNE, INC.
Model
A-100
Device description
AA Assay Cartridge, Single Use Packaged
Published
2019-01-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JOZSystem, Automated Platelet Aggregation

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856893004017PackageGS120In Commercial Distribution
20856893004014PackageGS120In Commercial Distribution
00856893004010PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085689300401710856893004017
2085689300401420856893004014
00856893004010008568930040108568930040100856893004010

GMDN Terms#

Term, Definition table
TermDefinition
Platelet aggregation study IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents, which may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius

Regulatory Flags#

DUNS number
078703793
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856893004027AggreguideA-100120202019-09-23
00856893004065AggreguideA-1002019-01-01
20856893004014AggreDYNE AA AssayA-1002019-01-01
00856893004041AggreguideA-1002019-01-01

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
04589448510013T-TAS 01 Total Thrombus Formation Analysis SystemZACROS CORPORATIONJOZ2024-12-06
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
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