Home GUDID 10853539002185 ScoutPro Osmolarity System
Primary DI 10853539002185
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 New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile false
Single use false 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 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch false Serial number true Manufacturing date on label true Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false 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 00853539002188 ScoutPro Osmolarity System 100094 2022-12-06 10853539002048 Osmolarity Normal Control Solutions 100012 2024-01-05 10853539002055 Osmolarity High Control Solution 100013 2024-01-05
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 00853539002188 ScoutPro Osmolarity System Tearlab Corporation OND 2022-12-06