FDA.reportPublic FDA data

VisuCal-F Frozen Calibrator Plasma

Primary DI
10629009041257
Brand
VisuCal-F Frozen Calibrator Plasma
Company
Affinity Biologicals Inc
Model
FRSP0125
Device description
Intended for use in the calibration of coagulation and fibrinolysis assays.
Published
2017-04-28
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIXCalibrator, Multi-Analyte Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIXCalibrator, Multi-Analyte MixtureClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K091284000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K091284000VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMAAffinity Biologicals, Inc.2009-10-28GGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16290090041255PreviousGS10
10629009041257PrimaryGS10
10629009040014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1629009004125516290090041255
1062900904125710629009041257
1062900904001410629009040014

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at or below -60°C.

Contacts#

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

Regulatory Flags#

DUNS number
249373515
Device count
25
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
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
10629009140516Sheep anti-human Factor XIII Analyte Specific ReagentSAFXIII-IG-ASR-52022-09-23

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