FDA.reportPublic FDA data

VisuLize Factor FVIII Antigen Kit

Primary DI
10629009010000
Brand
VisuLize Factor FVIII Antigen Kit
Company
Affinity Biologicals Inc
Model
FVIII-AG
Device description
96 Test enzyme immunoassay kit for the determination of FVIII Antigen
Published
2017-04-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K052825000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052825000VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AGAffinity Biologicals, Inc.2006-01-20GGP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16290090010008PreviousGS10
10629009010000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1629009001000816290090010008
1062900901000010629009010000

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation factor VIII IVD, kit, enzyme immunoassay (EIA)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of coagulation factor VIII in a clinical specimen, using an enzyme immunoassay (EIA) method. Factor VIII deficiency results in the X-linked congenital bleeding disorder known as haemophilia A.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do Not Freeze
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-800-903-6020info@affinitybiologicals.com

Regulatory Flags#

DUNS number
249373515
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10629009031050VisuCon-F Low Fibrinogen Control PlasmaLFGCP01052017-04-28
10629009031258VisuCon-F Low Fibrinogen Control PlasmaLFGCP01252017-04-28
10629009031814VisuCon-F Low Fibrinogen Control PlasmaLFGCP01812017-04-28
10629009041059Visu-Cal F Frozen Calibrator PlasmaFRSP01052017-04-28
10629009041257VisuCal-F Frozen Calibrator PlasmaFRSP01252017-04-28
10629009051058VisuCon-F Frozen Calibrator PlasmaFRNCP01052017-04-28
10629009051256VisuCon-F Frozen Normal Control PlasmaFRNCP01252017-04-28
10629009061057VisuCon-F Frozen Abnormal Control PlasmaFRABP01052017-04-28
10629009061255VisuCon-F Frozen Abnormal Control PlasmaFRABP01252017-04-28
10629009071254VisuCon-F Frozen Coag Screen NFCSN01252017-04-28
10629009071810VisuCon-F Frozen Coag Screen NFCSN01812017-04-28
10629009074811VisuCon-F Frozen Coag Screen NFCSN04812017-04-28
10629009081253VisuCon-F Frozen Coag Screen ABNFCSAB01252017-04-28
10629009081819VisuCon-F Frozen Coag Screen ABNFCSAB01812017-04-28
10629009084810VisuCon-F Frozen Coag Screen ABNFCSAB04812017-04-28
10629009091108VisuCon-L Coag Screen N PlasmaLSCN012018-10-19
10629009101104VisuCon-L Coag Screen ABN1 PlasmaLCSAB1012018-10-19
10629009111103VisuCon-L Coag Screen ABN2 PlasmaLCSAB2012018-10-19
10629009121102VisuCon-L(TM) Abnormal Control PlasmaLYABP012019-10-22
10629009131101VisuCon-L(TM) Normal Control PlasmaLYNCP012019-10-22

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
G0561012580Lyophilized Platelets Bio/Data CorporationGGP2022-03-23
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
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