Corowell COVID-19 Symptom Screening Test 001

GUDID 14260698980012

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.

MKG Consulting UG (haftungsbeschränkt)

Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick Olfactory test stick
Primary Device ID14260698980012
NIH Device Record Keyee48a58b-6cb2-4246-b323-b10704b9bf67
Commercial Distribution StatusIn Commercial Distribution
Brand NameCorowell COVID-19 Symptom Screening Test
Version Model Number1
Catalog Number001
Company DUNS314278450
Company NameMKG Consulting UG (haftungsbeschränkt)
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com
Phone+49264190828
Emailinfo@corowell.com

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104260698980015 [Primary]
GS104260698980022 [Package]
Contains: 04260698980015
Package: pack [10 Units]
In Commercial Distribution
GS104260698980046 [Package]
Contains: 04260698980015
Package: pack [3 Units]
Discontinued: 2021-08-11
Not in Commercial Distribution
GS104260698980053 [Package]
Contains: 04260698980015
Package: pack [5 Units]
Discontinued: 2021-08-11
Not in Commercial Distribution
GS114260698980012 [Package]
Contains: 04260698980015
Package: box [125 Units]
In Commercial Distribution
GS114260698980029 [Package]
Contains: 04260698980022
Package: carton [100 Units]
In Commercial Distribution
GS124260698980019 [Package]
Package: carton [20 Units]
In Commercial Distribution
GS124260698980026 [Package]
Contains: 14260698980029
Package: pallet [90 Units]
In Commercial Distribution
GS134260698980016 [Package]
Contains: 24260698980019
Package: pallet [40 Units]
In Commercial Distribution

FDA Product Code

NRKKit, Test, Olfactory

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-09
Device Publish Date2021-07-01
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.