Is Mira a registered FDA device class? or a CLIA waived?Updated 3 months ago

Mira is an FDA-registered Class I medical device. It is designed for at-home use and does not require CLIA certification, as it is not a laboratory-based test.

While Mira is not “FDA-cleared” (a designation reserved for higher-risk diagnostic devices), it is compliant with FDA regulations for low-risk wellness and fertility monitoring tools. The technology used in Mira has been clinically validated and supported by peer-reviewed research.
Mira meets the highest standards for medical devices: 

• ISO 13485 Certified: Ensuring top-tier medical device quality & compliance.
• MDSAP compliant: Meeting regulatory requirements across the US, Canada and Australia.
• FDA Registered: Compliant with U.S. medical device regulations for safety and efficacy.

Quanovate Tech, Inc. has been registered by Intertek, an MDSAP recognized auditingorganization, as conforming to the requirements of: ISO 13485:2016Australia: Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1(excluding Part 1.6)Canada: Medical Devices Regulations – Part 1- SOR 98/282United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D)