LipidPlus® Meter

GUDID 10763924550507

Lipid and Glucose Measuring System

JANT PHARMACAL CORPORATION

Glycated haemoglobin (HbA1c) monitoring system IVD, home-use
Primary Device ID10763924550507
NIH Device Record Key9162d105-0f41-4cbc-a103-a37397979360
Commercial Distribution StatusIn Commercial Distribution
Brand NameLipidPlus® Meter
Version Model NumberMD550
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 Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Operating and Storage Conditions

Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS110763924550507 [Primary]

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 Number4
Public Version Date2019-11-27
Device Publish Date2017-02-16

Devices Manufactured by JANT PHARMACAL CORPORATION

10763924550507 - LipidPlus® Meter2019-11-27Lipid and Glucose Measuring System
10763924550507 - LipidPlus® Meter2019-11-27 Lipid and Glucose Measuring System
10763924607058 - Accutest iFOB Positive and Negative Hemoglobin Controls2019-11-20 Accutest iFOB Positive and Negative Hemoglobin Controls Contains: 1 positive hemoglobin control and 1 negative hemoglobin control
20763924897104 - Accustrip URS Strips + Reader2018-07-06 Accustrip URS 10 parameter Strips and Accustrip URS Reader
00763924540105 - LipidPlus® Glucose Test Strips2018-07-06 Lipid and Glucose Measuring System

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