FDA.reportPublic FDA data

EasyGluco™G2 Starter Kit

Primary DI
00885502000037
Brand
EasyGluco™G2 Starter Kit
Company
U.S. DIAGNOSTICS INC.
Model
IGM-0008
Catalog number
IGM-G2-101
Published
2017-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CGAGlucose Oxidase, Glucose
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
NBWSystem, Test, Blood Glucose, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CGAGlucose Oxidase, GlucoseClinical Chemistry2
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)Clinical Chemistry1
NBWSystem, Test, Blood Glucose, Over The CounterClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K061431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061431000EASYGLUCO, MODEL IGM-0002 G2U. S. Diagnostics, Inc.2007-01-12CGA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885502000037PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885502000037008855020000378855020000370885502000037

GMDN Terms#

Term, Definition table
TermDefinition
Glucose monitoring system IVD, home-useA collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, test strips and/or other associated materials and accessories (e.g., control solutions, lancets) intended to be used for the quantitative measurement of glucose in a whole blood clinical specimen; it is designed to be used for self-testing by a layperson in the home, and some types may in addition be used at the point-of-care. Measured glucose values are used to manage blood glucose levels, primarily by persons with diabetes mellitus.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume1.5Microliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature50 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-216-5308jkupar@usdiagnostics.net

Regulatory Flags#

DUNS number
828116728
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
10885502002038EasyGluco™G2 Test StripsIGM-0008IGM-G2-2032017-01-13
10885502002199Easygluco® Plus Test StripsIGM-0035G8-203S502017-01-13
10885502002007INFINITY™ Test StripsIGM-0024G5-203S502017-01-13
10885502002045Control™ Test StripsIGM-0009IGM-G3-2032017-10-26
00885502002031EasyGluco™G2 Test StripsIGM-0008IGM-G2-2032017-01-13
00885502000006INFINITY™ Starter KitIGM-0024G5-003SK2017-01-13
00885502000044Control™ Starter KitIGM-0009IGM-G3-0032017-10-26
00885502001003INFINITY™ Meter KitIGM-0024G5-103MK2017-01-13
00885502001034EasyGluco™G2 Meter KitIGM-0008IGM-G2-1032017-01-13
00885502001041Control™ Meter KitIGM-0009IGM-G3-1032017-10-26
00885502004004INFINITY™ Normal Control SolutionIGM-00242018-09-24
00885502004035EasyGluco™ Normal Control SolutionIGM-0008IGMNORM2018-09-24
00885502015000INFINITY™ Low Control SolutionIGM-00242018-09-24
00885502015031EasyGluco™ Low Control SolutionIGM-0008IGMLOW2018-09-24
00885502016007INFINITY™ High Control SolutionIGM-00242018-09-24
00885502016038EasyGluco™ High Control SolutionIGM-0008IGMHI2018-09-24

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Primary DI, Brand, Company table
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00630414622859Atellica IM Tumor Marker Quality Control (TM QC)Siemens Healthcare Diagnostics Inc.JJX2026-05-29
00860015786869True IntegralTRUE INTEGRAL INCNBW2026-05-27
00860015786876True IntegralTRUE INTEGRAL INCNBW2026-05-27
07613336234457PreciControl SyphilisRoche Diagnostics GmbHJJX2026-05-15
08500835120024Diabetes Starter KitOptum Distribution Center, LLCNBW2026-04-21
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10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
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08718734960584Eurotrol GlucoTrol-NG Eurotrol B.V.JJX2020-10-08
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08718734960621Eurotrol AlbuTrolEurotrol B.V.JJX2020-10-08
08718734960645Eurotrol AlbuTrolEurotrol B.V.JJX2020-10-08
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
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08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
10054749005519i-STATABBOTT POINT OF CARE INC.CGA2020-05-01
10096295139553TRUE METRIXTRIVIDIA HEALTH, INC.NBW2020-04-10