FDA.reportPublic FDA data

Lyophilized Platelets

Primary DI
G0561012580
Brand
Lyophilized Platelets
Company
Bio/Data Corporation
Model
10mL
Catalog number
101258
Published
2022-03-23
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
GGPTest, Qualitative And Quantitative Factor Deficiency

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGPTest, Qualitative And Quantitative Factor DeficiencyHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G0561012580PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
von Willebrand factor: ristocetin cofactor complex activity (vWF:RCO) 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 quantitative measurement of von Willebrand factor:ristocetin cofactor complex activity (vWF:RCO) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
051392959
Device count
1
Lot or batch
true
Expiration 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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00843876000602CRYOcheck Factor VIII ChromogenicPrecision Biologic IncGGP2025-11-25
00630414320366BC von Willebrand ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-09-12
00842768018800BC von Willebrand ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-09-12
00195226001129HemosIL Chromogenic Factor IXINSTRUMENTATION LABORATORY COMPANYGGP2024-07-09
00630414640433vWF AgSiemens Healthcare Diagnostics Products GmbHGGP2024-03-29
00630414639437Berichrom a2-AntiplasminSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639628Berichrom Protein CSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639710Berichrom Protein CSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414639826INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640389Factor VIII Chromogenic AssaySiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640457Protein S AcSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00630414640655Protein C ReagentSiemens Healthcare Diagnostics Products GmbHGGP2024-03-25
00842768006661vWF AgSiemens Healthcare Diagnostics Products GmbHGGP2023-06-16
00843876000565CRYOcheck Chromogenic Factor IXPrecision Biologic IncGGP2023-01-06
G0561012691vW Normal Reference PlasmaBio/Data CorporationGGP2022-03-23
G0561012701vW Abnormal Control PlasmaBio/Data CorporationGGP2022-03-23
G0561015951Lyophilized Platelets Bio/Data CorporationGGP2022-03-23
G0561030251vW Factor Assay (Ristocetin Cofactor)Bio/Data CorporationGGP2022-03-23
G0561064261vW Normal Control PlasmaBio/Data CorporationGGP2022-03-23
G0561067301vW Select Kit (Ristocetin Cofactor)Bio/Data CorporationGGP2022-03-23
00843876000558CRYOcheck Factor VIII ChromogenicPrecision Biologic IncGGP2020-07-27
08600000686048VFERamco Laboratories, Inc.GGP2019-03-26
00843876000503CRYOcheck™ FVIII Inhibitor KitPrecision Biologic IncGGP2019-03-25
00842768039522INNOVANCE Free PS AgSiemens Healthcare Diagnostics Products GmbHGGP2018-11-15
03607450007374STA® - Staclot® Protein C 3DIAGNOSTICA STAGOGGP2017-12-06
10629009010000VisuLize Factor FVIII Antigen KitAffinity Biologicals IncGGP2017-04-28
10629009020009VisuLize Factor FIX Antigen KitAffinity Biologicals IncGGP2017-04-28
00859394006095ThromboTek PSeR 2 DIAGNOSTICS, INC.GGP2016-11-15
00811476010000Chrono-logCHRONO-LOG CORPGGP2016-10-11
00811476010017Chrono-logCHRONO-LOG CORPGGP2016-10-11