FDA.reportPublic FDA data

AGG/PAK 5 Combo Kit

Primary DI
G0561076501
Brand
AGG/PAK 5 Combo Kit
Company
Bio/Data Corporation
Model
107650
Catalog number
107650
Published
2024-10-01
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K790769000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K790769000BETA/PAKBio/Data Corp.1979-05-03JOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G0561076501PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Platelet aggregation study IVD, kit, nephelometry/turbidimetryA collection of reagents and other associated materials intended to be used for the qualitative evaluation of platelet aggregation in a clinical specimen using one or multiple platelet aggregation agents and a nephelometry/turbidimetry method. Platelet aggregation agents used may include adenosine diphosphate, collagen, epinephrine, thrombin, arachidonic acid and/or ristocetin.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051392959
Device count
1
Combination product
true
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
G0561059771Stir Bars, Macro1059771059772023-08-30
G0561059901Stir Bars, Micro1059901059902023-08-30
G0561003361Test Tubes, Macro1003361003362023-08-30
G0561009890Calcium Chloride10098910099892023-08-30
G0561009910Tris Buffered Saline1009911009912023-08-30
G0561009940Sodium Citrate1009941009942023-08-30
G0561013751Profiler Paper1013751013752023-08-30
G0561015211Test Tubes, Micro1015211015212023-08-30
G0561055981Printer Paper1055981055982023-08-30
G0561060771Platelet Aggregometer ProfilerPAP-8E1060772023-08-30
G0561068421PDQ Platelet Centrifuge1068421068422023-08-30
G0561068521Transfer Pipettes, Disposable1068521068522023-08-30
G0561068531Sample Tubes1068531068532023-08-30
G0561068991Sample Tube Caps1068991068992023-08-30
G0561071170LTA Check Test Kit1071171071172023-08-30
G0561071461MagneTube1071461071462023-08-30
G0561071490LTA Check CD1071491071492023-08-30
G0561071530PAP-8E Software CD1071531070532023-08-30
G0561060751Platelet Aggregometer ProfilerPAP8E1060752022-03-23
G0561013101PAR/PAK II1013101013102022-03-23

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
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