Instructions, resources, and other helpful product information
Helpful product information to guide your path forward
Advanced Rhinostics nasal swabs and nasopharyngeal swabs are ideal for COVID test needs as well as tests for respiratory pathogens, respiratory syncytial virus (RSV), influenza (Flu), and more. Additionally, our swabs are manufactured independent of fragile traditional swab supply channels. Scroll down to access Rhinostics resources including swab instruction guides, product information, regulatory documentation, and more.
Harvard University Clinical Lab only
HUCL instructions for use
Step-by-step guide exclusive to the COVID-19 Self-Swab Collection Kit for Harvard University Clinical Laboratory. For general instructions, click below.
HUCL INSTRUCTIONSHarvard University Clinical Lab only
HUCL emergency use authorization (EUA)
Emergency use authorization summary exclusive to the Quaeris SARS-CoV-2 Assay, including a performance comparison of the RHINOstic Automated Nasal Swab and an FDA cleared swab, conducted at the Harvard University Clinical Laboratory. For general EUA documentation, click below.
HUCL EUA SUMMARYHelp is here
Rhinostics Resources, Including Instructions for Use and Specifications
Applies to RH-100001 | LV-2D00001 | LV-2D1D001 | LV-2D1D002
RHINOstic™ Automated Nasal Swab
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Applies to PG-100001 | PG-100011
Rhinostics Standard Nasal Swab
VIEW PRODUCTApplies to GW-UF10001 | GW-F100001
Rhinostics GrooveSwab™ Nasopharyngeal Swab
VIEW PRODUCTAdditional Downloads
Publications related to Rhinostics swab technologies
Regulatory information
U.S. FDA Class I Exempt Medical Device
The RHINOstic Automated Nasal Swab collection device, Rhinostics Standard Nasal Swab, and Rhinostics GrooveSwab Nasopharyngeal Swab are registered as Class I Exempt Medical Devices with the United States Food and Drug Administration (U.S. FDA). They are exempt from 510(k) and Premarket Approval (PMA) requirements. Each lot of the RHINOstic Automated Nasal Swab and the Rhinostics Standard Nasal Swab are sterilized with gamma irradiation, and the GrooveSwab Nasopharyngeal Swab is sterilized using ethylene oxide. A representative sample of each lot is evaluated for bioburden, and all testing procedures are established per the definitions in M40-A2: Quality Control of Microbiological Transport Systems, 2nd Edition as put forth by the Clinical and Laboratory Standards Institute.
More Information Coming Soon
Rhinostics is ever growing to suit patients’ and medical professionals’ needs. Check back soon for more regulatory information.
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