LipidPlus® Glucose Test Strips

GUDID 00763924540105

Lipid and Glucose Measuring System

JANT PHARMACAL CORPORATION

Glucose IVD, kit, electrometry Glucose IVD, kit, electrometry
Primary Device ID00763924540105
NIH Device Record Key553651d3-8f4d-42e6-bfb4-b6ee37406540
Commercial Distribution StatusIn Commercial Distribution
Brand NameLipidPlus® Glucose Test Strips
Version Model NumberMD540
Company DUNS797393659
Company NameJANT PHARMACAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Dimensions

Total Volume0.3 Microliter
Total Volume0.3 Microliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit
Storage Environment TemperatureBetween 36 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100763924540105 [Primary]
GS110763924540102 [Package]
Package: [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-02-16

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Trademark Results [LipidPlus]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LIPIDPLUS
LIPIDPLUS
77939315 3887971 Live/Registered
Jant Pharmacal Corporation
2010-02-18

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