Sensonics' Microencapsulated Smell Tests

Basic Information

• Brand Name: Sensonics' Microencapsulated Smell Tests
• Primary DI: G051QSIT0
• Version / Model: QSIT
• Company Name: Sensonics, Inc.
• Labeler DUNS: 107213563
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-01-29
• Public Version: 1
• Public Version Date: 2025-02-06
• Public Version Status: New
• Public Device Record Key: 694b67f2-7d58-4faf-b1ec-70d8317f78dc

Device Description

The Quick Smell Identification Test or Q-SIT® is a rapid assessment of smell ability for bedside/medical applications. The Q-SIT® comes in convenient booklets of 20 pages. Each page has a tear-off portion for presentation to the patient. The tear-off portion contains three microencapsulated odorants with the standard 4-choice identification options. If the patient misses one or more items, testing with Sensonics International’s 40-item Smell Identification Test is suggested in order to assess the degree of smell loss.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NRK	Kit, Test, Olfactory	Ear, Nose, Throat	874.1600	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65154	Olfactory test stick	A non-powered, scented device intended to be used to assess a patient’s olfactory function (normosmia, hyposmia, or anosmia). It typically consists of a scented stick(s) intended to be sniffed by the patient, followed by patient description of smell perception. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G051QSIT0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]