FDA.reportPublic FDA data

LipidPlus® Glucose Test Strips

Primary DI
00763924540105
Brand
LipidPlus® Glucose Test Strips
Company
JANT PHARMACAL CORPORATION
Model
MD540
Device description
Lipid and Glucose Measuring System
Published
2017-02-16
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
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
K130295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130295000LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM.Infopia Co, Ltd.2013-06-21NBW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763924540102PackageGS12In Commercial Distribution
00763924540105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076392454010210763924540102
00763924540105007639245401057639245401050763924540105

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume0.3Microliter

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
797393659
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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