FDA.reportPublic FDA data

Scentific Test Kit

Primary DI
07290019255109
Brand
Scentific Test Kit
Company
APPSCENT MEDICAL LTD
Model
1
Catalog number
02U111000
Device description
The Scentific test device is used to determine whether an olfactory loss is present. The device includes scents that are presented to the patient's nose to subjectively assess the patient's ability to perceive scents.
Published
2026-02-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
07290019255109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290019255109072900192551097290019255109

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 Atmospheric Pressure77 KiloPascal101 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure77 KiloPascal101 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532387650
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290019255055SCENTIFIC Respiratory Biofeedback203U1110002026-02-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
04260676240155Sniffin' Sticks - Screening 12 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