FDA.reportPublic FDA data

Sniffin' Sticks - Screening 12 Test Refill Set

Primary DI
04260676240155
Brand
Sniffin' Sticks - Screening 12 Test Refill Set
Company
Burghart Messtechnik GmbH
Model
LA-13-00437
Catalog number
LA-13-00437
Device description
The Screening 12 Test is intended to be used for examination of smell disorders on humans. The test result can be used to differentiate between Normosmia, Hyposmia, and Anosmia, if the patient is cooperative.
Published
2021-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NRKKit, Test, Olfactory

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NRKKit, Test, OlfactoryEar, Nose, Throat2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260676240155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260676240155042606762401554260676240155

GMDN Terms#

Term, Definition table
TermDefinition
Olfactory test stickA 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Special Storage Condition, Specify00Keep away from sunlight
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4941038007619sabine.steinberg@burghart-mt.de

Regulatory Flags#

DUNS number
341406604
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260676240131Sniffin' Sticks - Extended Test Refill SetLA-13-00433LA-13-004332021-04-21
04260676240209Sniffin' Sticks - Odor QuartetLA-13-00434LA-13-004342021-04-21
04260676240124Sniffin' Sticks - Extended TestLA-13-00435LA-13-004352020-11-10
04260676240148Sniffin' Sticks - Screening 12LA-13-00436LA-13-004362020-11-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290019255109Scentific Test KitAPPSCENT MEDICAL LTDNRK2026-02-16
G051SSI0Sensonics' Snap & Sniff Eco-Friendly Olfactory Test SystemSensonics, Inc.NRK2025-03-11
G051SSOD0Sensonics' Snap & Sniff Eco-Friendly Olfactory Test SystemSensonics, Inc.NRK2025-03-11
G051SST0Sensonics' Snap & Sniff Eco-Friendly Olfactory Test SystemSensonics, Inc.NRK2025-03-11
G051PIT0Sensonics' Microencapsulated Smell TestsSensonics, Inc.NRK2025-01-30
G051BSIT9Sensonics' Microencapsulated Smell TestsSensonics, Inc.NRK2025-01-29
G051ODMT0Sensonics' Microencapsulated Smell TestsSensonics, Inc.NRK2025-01-29
G051PSIT9Sensonics' Microencapsulated Smell TestsSensonics, Inc.NRK2025-01-29
G051PSW0Sensonics' Microencapsulated Smell TestsSensonics, Inc.NRK2025-01-29
G051QSIT0Sensonics' Microencapsulated Smell TestsSensonics, Inc.NRK2025-01-29
G051SITT0Sensonics Microencapsulated Smell TestsSensonics, Inc.NRK2025-01-29
G051SNSD0Sensonics' Snap & Sniff Eco-Friendly Olfactory Test SystemSensonics, Inc.NRK2025-01-29
G051SNSI0Sensonics' Snap & Sniff Eco-Friendly Olfactory Test SystemSensonics, Inc.NRK2025-01-29
G051SNST0Sensonics' Snap & Sniff Eco-Friendly Olfactory Test SystemSensonics, Inc.NRK2025-01-29
04260698980015Corowell COVID-19 Symptom Screening TestMKG Consulting UG (haftungsbeschränkt)NRK2021-07-01
14260698980012Corowell COVID-19 Symptom Screening TestMKG Consulting UG (haftungsbeschränkt)NRK2021-07-01
04260676240131Sniffin' Sticks - Extended Test Refill SetBurghart Messtechnik GmbHNRK2021-04-21
04260676240209Sniffin' Sticks - Odor QuartetBurghart Messtechnik GmbHNRK2021-04-21
04260676240124Sniffin' Sticks - Extended TestBurghart Messtechnik GmbHNRK2020-11-10
04260676240148Sniffin' Sticks - Screening 12Burghart Messtechnik GmbHNRK2020-11-10