Home GUDID 10763924550507 LipidPlus® Meter
Primary DI 10763924550507
Brand LipidPlus® Meter
Company JANT PHARMACAL CORPORATION
Model MD550
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 Product Codes# Code, Name table Code Name CGA Glucose Oxidase, Glucose CHH Enzymatic Esterase--Oxidase, Cholesterol JGY Colorimetric Method, Triglycerides JJX Single (Specified) Analyte Controls (Assayed And Unassayed) LBR Ldl & Vldl Precipitation, Hdl NBW System, Test, Blood Glucose, Over The Counter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class CGA Glucose Oxidase, Glucose Clinical Chemistry 2 CHH Enzymatic Esterase--Oxidase, Cholesterol Clinical Chemistry 1 JGY Colorimetric Method, Triglycerides Clinical Chemistry 1 JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry 1 LBR Ldl & Vldl Precipitation, Hdl Clinical Chemistry 1 NBW System, Test, Blood Glucose, Over The Counter Clinical Chemistry 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10763924550507 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized table Source identifier GTIN-14 normalized 10763924550507 10763924550507
GMDN Terms# Term, Definition table Term Definition Glycated haemoglobin (HbA1c) monitoring system IVD, home-use A collection of devices including a portable, battery-powered, semi-automated or automated instrument (self-testing meter), reagents, and/or other associated disposable materials (e.g., lancet) intended to be used for the quantitative measurement of glycated haemoglobin (HbA1c) 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. The measurement is typically based on an immunological method (e.g., immunoassay) and/or spectrophotometry, and is used to evaluate the long-term control of blood glucose concentration, primarily in persons with diabetes mellitus.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature 64 Degrees Fahrenheit 86 Degrees Fahrenheit
Regulatory Flags# DUNS number 797393659 Device count 1 Lot or batch true Serial number true Manufacturing date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10763924750044 Accutest H. Pylori Urease Rapid Test ID750 2026-04-21 10763924601568 ACCUTEST Uriscreen Rapid Screen for UTI. Test ID601 2016-09-24 00763924540105 LipidPlus® Glucose Test Strips MD540 2017-02-16 10763924532107 LipidPlus® Total Cholesterol Test Strips MD532 2017-02-16 10763924851109 Accustrip VALUE+ hCG Urine Pregnancy Test Strip (CLIA Waived) PF851 2016-09-20 10763924853202 Accutest VALUE+™ hCG Urine Pregnancy Test Cassette (CLIA Waived) PF853 2016-09-20 10763924864208 Accutest VALUE+™ hCG Urine/Serum Pregnancy Test Cassette (CLIA-Waived for urine) PF864 2016-09-20 10763924320919 Accutest CLEAR MDMA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS320 2016-09-20 10763924095213 Accutest Breath Alcohol Detector DS95AC220 2016-09-24 10763924097224 Accustrip Saliva Alcohol Test DS97AC125 2016-09-24 10763924210142 Accutest UA702A 2016-09-24 10763924410146 Accutest UA704A 2016-09-24 10763924710147 Accutest UA710A 2016-09-24 10763924850508 Accustrip Urine Reagent Strip Reader UA850 2016-09-24 10763924870100 Accustrip 10-Parameter Urine Reagent Strip UA870 00763924870103 2016-09-24 10763924319913 Accutest CLEAR Marijuana/THC Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS319 2016-09-20 20763924897104 Accustrip URS Strips + Reader UA897 2016-09-24 10763924309914 Accutest CLEAR TCA Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS309 2016-09-20 10763924310910 Accutest CLEAR Oxycodone Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS310 2016-09-20 10763924311917 Accutest CLEAR Amphetamine Drug Screen Dip & Read. *CLIA-Waived* 25 Tests/Kit DS311 2016-09-20
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