FDA.reportPublic FDA data

Platelet Aggregometer Profiler

Primary DI
G0561060771
Brand
Platelet Aggregometer Profiler
Company
Bio/Data Corporation
Model
PAP-8E
Catalog number
106077
Device description
Platelet Aggregometer Profiler Model PAP-8E
Published
2023-08-30
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
JBXAggregrometer, Platelet

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBXAggregrometer, PlateletHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G0561060771PrimaryHIBCC0

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
051392959
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G0561076501AGG/PAK 5 Combo Kit1076501076502024-10-01
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
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
00811476011007CHRONO-LOGCHRONO-LOG CORPJBX2023-06-21
00811476011021CHRONO-LOGCHRONO-LOG CORPJBX2023-06-21
00811476011045CHRONO-LOGCHRONO-LOG CORPJBX2023-06-21
00811476011663CHRONO-LOGCHRONO-LOG CORPJBX2023-06-21
00811476011670CHRONO-LOGCHRONO-LOG CORPJBX2023-06-21
G0561060751Platelet Aggregometer ProfilerBio/Data CorporationJBX2022-03-23
00811476010369Chrono-logCHRONO-LOG CORPJBX2016-10-11
00811476010376Chrono-logCHRONO-LOG CORPJBX2016-10-11
00811476010963Chrono-logCHRONO-LOG CORPJBX2016-10-11
03607450009507Asserachrom® ß-TGDIAGNOSTICA STAGOJBX2016-09-15
M52553640Arachidonic AcidHELENA LABORATORIES CORPORATIONJBX2016-09-07