Pandemic Infection Symptoms & Predictors
"The occurrence of olfaction dysfunction with COVID-19 is demonstrated to be frequent, respectively from... 86% of cases."¹
"Olfactory dysfunction has been shown to be the strongest predictor of COVID-19 positivity when compared to other symptoms"²
Hyposmia is when the ability to detect odor is reduced and anosmia is when a person can't detect odor at all. Each scent is selected based on multiple criteria such as detection and cognition levels utilizing long-standing scientific literature.
Corowell continuously improves its proprietary scent portfolio, by customizing the scent intensities for an optimized pandemic infection-induced loss/impaired sense of smell detection. Operating the screening test in the human cognition zone allows for objective testing and optimizing of the overall test sensitivity.
Regulatory
Sensitivity: 89%
Specificity: 92%
Packaging options: 1,4,5,10, and 125 packs
FDA product code: NRK
FDA device class: Class II (exempt)
EU product classification: Medical Device Class I (MDD 93/42/EC)
Canadian device class: Class I
Production capacity: ~50 Million units per month
Manufacturing locations: United States and Germany
Data Privacy: No personal information kept on servers
FDA Registration
Proprietary Name: Corowell COVID-19 Symptom Screening Test
Classification Name: KIT, TEST, OLFACTORY
Product Code: NRK
Device Class: 2
Regulation Number: 874.1600
Medical Specialty: Ear Nose & Throat
Registered Establishment Name: MKG CONSULTING UG
Registered Establishment Number: 317865123