FDA.reportPublic FDA data

UniStrip1 Generic Blood Glucose Test Strip

Primary DI
00389167248501
Brand
UniStrip1 Generic Blood Glucose Test Strip
Company
Unistrip Technologies, LLC
Model
024850
Catalog number
024850
Device description
UniStrip1 Generic Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchased before October 2012.
Published
2016-09-24
Public version status
Update
Distribution status
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
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00389167348508PackageGS124In Commercial Distribution
00389167248501PrimaryGS10
00389167148504Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00389167348508003891673485083891673485080389167348508
00389167248501003891672485013891672485010389167248501
00389167148504003891671485043891671485040389167148504

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. It is typically in a strip format (e.g., screen-printed electrode) for use with a dedicated testing device (not included).

Regulatory Flags#

DUNS number
043251054
Device count
50
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00681131104869Equate Blood Glucose Test Strips0386000386002016-09-24
00389167362108UniStrip Control Solution Low0362100362102016-09-23
00681131304863Equate Blood Glucose Test Strips0386000386002016-09-24
00389167348508UniStrip1 Generic Blood Glucose Test Strip0248500248502016-09-24
00389167262101UniStrip Control Solution Low0362100362102016-09-23

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