Sniffin' Sticks - Extended Test Refill Set LA-13-00433

GUDID 04260676240131

Refill Kit for the Extended Test: The Extended Test (also called “TDI-Test“ – Threshold, Discrimination, Identification) consists of 3 individual tests. A threshold test, a discrimination test and an identi-fication test. Each of these tests generates a number of points, which is added up to the TDI score at the end. The user is given a diagnostic classification of the patient's ability to smell. This is done by evaluating the number of points achieved. For the score, also called TDI score, there are standard values, which were determined by a validation study. The maximum number of points is 48, which is divided between the 3 tests.

Burghart Messtechnik GmbH

Olfactory test stick

• Primary Device ID: 04260676240131
• NIH Device Record Key: b7d53dbc-7f19-4bd2-9db4-e84fed9ab27a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sniffin' Sticks - Extended Test Refill Set
• Version Model Number: LA-13-00433
• Catalog Number: LA-13-00433
• Company DUNS: 341406604
• Company Name: Burghart Messtechnik GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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

Customer Support Contacts

• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de
• Phone: +494103800760
• Email: info@burghart-mt.de

Operating and Storage Conditions

• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Storage Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	04260676240131 [Primary]

FDA Product Code

• NRK: Kit, Test, Olfactory

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: 2021-04-29
• Device Publish Date: 2021-04-21