| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 00853539002034 [Primary] | 
| GS1 | 10853539002031 [Unit of Use] | 
| OND | Osmolality Of Tears | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2025-09-05 | 
| Device Publish Date | 2025-08-28 | 
| 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. |