FDA.reportPublic FDA data

Corowell COVID-19 Symptom Screening Test

Primary DI
04260698980015
Brand
Corowell COVID-19 Symptom Screening Test
Company
MKG Consulting UG (haftungsbeschränkt)
Model
1
Catalog number
001
Device description
The Corowell COVID-19 Symptom Screening Test is intended to objectively testing of the sense of smell. It enables the identification of subjects whose olfactory perception is deviating, restricted or newly got lost.The Corowell COVID-19 Symptom Screening Test is a device for home use.The Corowell COVID-19 Symptom Screening Test can be performed self-administered by the subject.The target population is adults over 18 years of age.
Published
2021-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
04260698980022PackageGS110In Commercial Distribution
04260698980046PackageGS13Not in Commercial Distribution
04260698980053PackageGS15Not in Commercial Distribution
14260698980012PackageGS1125In Commercial Distribution
14260698980029PackageGS1100In Commercial Distribution
24260698980019PackageGS120In Commercial Distribution
24260698980026PackageGS190In Commercial Distribution
34260698980016PackageGS140In Commercial Distribution
04260698980015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260698980022042606989800224260698980022
04260698980046042606989800464260698980046
04260698980053042606989800534260698980053
1426069898001214260698980012
1426069898002914260698980029
2426069898001924260698980019
2426069898002624260698980026
3426069898001634260698980016
04260698980015042606989800154260698980015

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
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
+49264190828info@corowell.com

Regulatory Flags#

DUNS number
314278450
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
14260698980012Corowell COVID-19 Symptom Screening Test10012021-07-01

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
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