FDA.reportPublic FDA data

Easygluco® Plus Test Strips

Primary DI
10885502002199
Brand
Easygluco® Plus Test Strips
Company
U.S. DIAGNOSTICS INC.
Model
IGM-0035
Catalog number
G8-203S50
Published
2017-01-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110435000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110435000EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEMU. S. Diagnostics, Inc.2011-09-21NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885502002192PackageGS12In Commercial Distribution
10885502002199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885502002192008855020021928855020021920885502002192
1088550200219910885502002199

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).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.5Microliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

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

Regulatory Flags#

DUNS number
828116728
Device count
1
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
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
00885502000037EasyGluco™G2 Starter KitIGM-0008IGM-G2-1012017-01-13
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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10612479280486McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2025-12-01
10840330705681TRUE METRIX PROTRIVIDIA HEALTH, INC.NBW2025-10-02
10385540109749CareSens SAgaMatrix, Inc.NBW2025-08-04
10612479265513McKessonMCKESSON MEDICAL-SURGICAL INC.NBW2023-05-17
10385480631645Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631652Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480631669Nova Primary NOVA BIOMEDICAL CORPORATIONCGA2023-02-24
10385480632307Nova PrimaryNOVA BIOMEDICAL CORPORATIONCGA2023-02-22
10673486000719TECO DIAGNOSTICSTECO DIAGNOSTICSCGA2022-08-09
08806128351534metene Blood Glucose Test StripAll Medicus Co.,Ltd.NBW2021-12-24
10760236150357Meijer Essential Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150364Meijer Essential Wireless Blood Glucose MeterMEIJER, INC.NBW2021-11-05
10760236150371Meijer Essential Blood Glucose Test StripsMEIJER, INC.NBW2021-11-05
10888277365940MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.NBW2021-10-01
10050428265106CVS Glucose MeterWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428293307CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10050428299118CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDNBW2021-03-22
10888277409187MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-11
10888277675681MedlineMEDLINE INDUSTRIES, INC.NBW2020-12-11
10888277409170MedlineMEDLINE INDUSTRIES, INC.CGA2020-12-10
10884389831205MedlineMEDLINE INDUSTRIES, INC.NBW2020-11-24
08809115905796Oh'care Lite Smart Glucose Test StripOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809115905802Oh'care Lite Smart Glucose MeterOSANG HEALTHCARE Co., Ltd.NBW2020-11-05
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdNBW2020-09-11
08809301161760Pip Blood Glucose Test StripsPHILOSYS Co., LtdCGA2020-09-11
08809301160862Pip Blood Glucose Monitoring SystemPHILOSYS Co., LtdCGA2020-09-11
10612479250434MckessonMCKESSON MEDICAL-SURGICAL INC.NBW2020-08-19