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Kit, Test, Olfactory

Kit, Test, Olfactory is a medical device type in the Ear, Nose, Throat 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.

Global Registration Data
Multi-Country Intelligence
Kit, Test, Olfactory
Ear, Nose, Throat Medical Device Type
Pure Global
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Regulatory Classifications

US Regulatory Classifications

NRK

View Product Code Classification

Class 2

21 CFR 874.1600

View CFR Regulation

Ear, Nose, Throat

Device Characteristics

No

No

No

Not Eligible

Definition

The home test for loss of the sense of smell is packaged in a small carton which contains (1) an instruction book, (2) a booklet containing twelve micorencapsulated smell strips, each on a separate page, with instructions for scoring the test and an answer key, and (3) a physician information card. The device is intended for screening neurological disorder.