Instructions, resources, and other helpful product information

Rhinostics Resources and Knowledge Repository

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 INSTRUCTIONS

Harvard 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 SUMMARY

Regulatory information

U.S. FDA Class I Exempt Medical Device

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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

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Rhinostics is ever growing to suit patients’ and medical professionals’ needs.  Check back soon for more regulatory information.

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