TearLab Osmolarity Test Card

GUDID 00853539002034

Tearlab Corporation

Osmolality IVD, reagent

• Primary Device ID: 00853539002034
• NIH Device Record Key: cbcaa2ce-bbb0-4786-9576-c58a41e1d218
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TearLab Osmolarity Test Card
• Version Model Number: 100003
• Company DUNS: 155813749
• Company Name: Tearlab Corporation
• Device Count: 100000
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00853539002034 [Primary]
GS1	10853539002031 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083184

FDA Product Code

• OND: Osmolality Of Tears

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-05
• Device Publish Date: 2025-08-28

Devices Manufactured by Tearlab Corporation

• 00853539002034 - TearLab Osmolarity Test Card: 2025-09-05
• 00853539002034 - TearLab Osmolarity Test Card: 2025-09-05
• 10853539002048 - Osmolarity Normal Control Solutions: 2024-01-15
• 10853539002055 - Osmolarity High Control Solution: 2024-01-15
• 10853539002185 - ScoutPro Osmolarity System: 2022-12-14 In-vitro analysis of ocular tear fluid.