FDA.reportPublic FDA data

Easy Talk

Primary DI
04719871820162
Brand
Easy Talk
Company
BIOTEST MEDICAL CORPORATION
Model
8818(BY8818G0NL4)
Device description
Easy Talk Blood Glucose Test Strip(25pc/vial)
Published
2016-05-02
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBXStimulator, Electrical, Implanted, Functional (For Lower Limb Mobility)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBXStimulator, Electrical, Implanted, Functional (For Lower Limb Mobility)

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719871820162PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719871820162047198718201624719871820162

GMDN Terms#

Term, Definition table
TermDefinition
Glucose IVD, kit, electrometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of glucose in a clinical specimen, using an electrometry method.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658447255
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04719871820070Easy Plus II8818(BY8818G0NL4)2016-05-02
04719871820100Easy Plus II 8818(BZ8818G0HAB)2016-05-02
04719871820155Easy Talk8818(BZ8818G0HAA)2016-05-02
04719871820230Oracle8818/BL8818ROA2016-11-29
04719871820261Perfect 388182017-02-23
04719871820339NuvoMed58192018-03-07
04719871820315NuvoMed P5228 BGM-6/0352 2018-03-07
04719871820322NuvoMed P5228 BGM-6/0352 2018-03-07
04719871820001Smartest PersonaII6276-S2016-03-02
04719871820018Smartest PersonaII 88192016-03-02
04719871820025Smartest PersonaIIGOD212016-03-02
04719871820032Smartest PersonaII 6276-S2016-03-02
04719871820049B T M82282016-03-02
04719871820056Easy Plus II6276-S(BZG60276HA)2016-05-02
04719871820063Easy Plus II6276-S(BYG60276HA)2016-05-02
04719871820087Easy Plus IIGOD11(BYGOD31BT)2016-05-02
04719871820094Easy Plus IIGOD31(BZL001HAB)2016-05-02
04719871820117Easy Plus IIGOD31(BZH002HAB)2016-05-02
04719871820124Easy Plus IIGOD11(BZL002HAB)2016-05-02
04719871820131Easy Talk6277(BZG62277HAA)2016-05-02

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