FDA.reportPublic FDA data

Sheep anti-human Factor XIII Analyte Specific Reagent

Primary DI
10629009140516
Brand
Sheep anti-human Factor XIII Analyte Specific Reagent
Company
Affinity Biologicals Inc
Model
SAFXIII-IG-ASR-5
Device description
The specific use of this ASR (Analyte Specific Reagent) will depend upon the end-user's application.
Published
2022-09-23
Public version status
New
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
MVUReagents, Specific, Analyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVUReagents, Specific, AnalytePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10629009140516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1062900914051610629009140516

GMDN Terms#

Term, Definition table
TermDefinition
Assay development analyte-specific reagent IVDAn antibody, specific receptor protein, ligand, nucleic acid sequence (e.g., primer, probe) or similar reagent, which through specific binding or chemical reaction with an intended target, is used to identify or quantify a chemical substance in a biological specimen for the development of a laboratory developed test (LDT) or commercial in vitro diagnostic medical device (IVD). Commonly referred to as an analyte specific reagent (ASR), it is neither labelled with instructions for use nor diagnostic or performance claims.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius-10 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
249373515
Device count
1
Premarket exempt
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03661540953217DSQ Alert Hepatitis E Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953224DSQ Alert Hepatitis E Probe Mix ASRElitechgroup Mdx LLCMVU2026-08-07
03661540953279DSQ Alert Mycoplasma pneumoniae Primer Mix ASRElitechgroup Mdx LLCMVU2026-08-07
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