FDA product code OND

Osmolality Of Tears

Clinical Chemistry·Class 1·21 CFR 862.1540
US regulatory classifications
US Product Code (FDA)
OND
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 862.1540
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Medical specialty
Clinical Chemistry
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

To measure the osmolality of human tears to aid in the diagnosis of patients with signs or symptoms of dry eye disease, in conjunction with other methods of clinical evaluation.

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About this record

Osmolality Of Tears is a medical device type in the Clinical Chemistry specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.