Home GUDID 00853539002188 ScoutPro Osmolarity System
Primary DI 00853539002188
Brand ScoutPro Osmolarity System
Company Tearlab Corporation
Model 100094
Device description In-vitro analysis of ocular tear fluid.
Published 2022-12-06
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name OND Osmolality Of Tears
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class OND Osmolality Of Tears Clinical Chemistry 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00853539002188 Primary GS1 0 10853539002185 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00853539002188 00853539002188 853539002188 0853539002188 10853539002185 10853539002185
GMDN Terms# Term, Definition table Term Definition Osmometric analyser IVD An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative determination of the osmotic concentration of a clinical specimen (e.g., urine, serum, tears, sweat) by comparing its freezing-point depression curve, or vapour-pressure depression curve, with that of a standard solution. It is often used to assess an abnormal osmolar ratio which may indicate disease [e.g., renal disease, diabetes insipidus, secretion of abnormal levels of antidiuretic hormone (ADH)].
Regulatory Flags# DUNS number 155813749 Device count 200 Premarket exempt 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 00853539002034 TearLab Osmolarity Test Card 100003 2025-08-28 00853539002041 Osmolarity Normal Control Solutions 100012 2024-01-05 00853539002058 Osmolarity High Control Solution 100013 2024-01-05 10853539002048 Osmolarity Normal Control Solutions 100012 2024-01-05 10853539002055 Osmolarity High Control Solution 100013 2024-01-05 10853539002185 ScoutPro Osmolarity System 100094 2022-12-06
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00853539002034 TearLab Osmolarity Test Card Tearlab Corporation OND 2025-08-28 10853539002185 ScoutPro Osmolarity System Tearlab Corporation OND 2022-12-06