Question 1

What types of medical devices does Co-Diagnostics, Inc. manufacture?

Accepted Answer

Co-Diagnostics, Inc. specializes in rapid on-site PCR (Polymerase Chain Reaction) testing devices for infectious disease detection. Their portfolio includes the Logix Smart ZDC for diagnosing Zika, Dengue, and Chikungunya; the Logix Smart ABC for Influenza A/B and SARS-CoV-2 detection; and the Logix Smart MTB Test Kit for tuberculosis. These devices are designed to amplify and detect genetic material from clinical samples in real-time, enabling quick diagnostic results at the point of care.

Question 2

Where is Co-Diagnostics, Inc. based, and what is its primary focus?

Accepted Answer

Co-Diagnostics, Inc. is based in the United States. The company focuses on developing PCR-based diagnostic solutions that enable rapid, on-site detection of infectious diseases. Their technology leverages amplification of genetic material to provide accurate results quickly, supporting timely clinical decision-making.

Question 3

Are Co-Diagnostics, Inc. devices listed in any regulatory registries?

Accepted Answer

Yes, Co-Diagnostics, Inc. devices are registered in the EU’s eudamed database. This registry is used to track In Vitro Diagnostic (IVD) medical devices authorized for use within the European Economic Area. Registration in eudamed ensures transparency and compliance with EU regulatory requirements for IVD devices.

Question 4

How are Co-Diagnostics, Inc. devices classified under regulatory frameworks?

Accepted Answer

Co-Diagnostics, Inc. devices fall under the IVD General classification category. This classification applies to in vitro diagnostic medical devices that do not pose significant risks and are typically used for routine diagnostic purposes. The IVD General category includes devices like PCR-based tests, which are essential for detecting infectious diseases but are not considered high-risk.

Device	Model / Reference	Registries	Class	Status
Synovasure® Alpha Defensin	00-8888-125-05	FDA UDI	Class II	Active
Synovasure®	00-8888-125-30	FDA UDI	Class II	Active
Synovasure® Alpha Defensin	00-8888-125-30	FDA UDI	Class II	Active
Synovasure® Alpha Defensin	00-8888-125-05	FDA UDI	Class II	Active
Synovasure®	00-8888-125-10	FDA UDI	Class II	Active
Synovasure® Alpha Defensin	00-8888-125-02	FDA UDI	Class II	Active
Synovasure® Alpha Defensin	00-8888-125-01	FDA UDI	Class II	Active
Synovasure® Alpha Defensin	00-8888-125-10	FDA UDI	Class II	Active
Synovasure® Alpha Defensin	00-8888-125-01	FDA UDI	Class II	Active
Synovasure® Alpha Defensin	00-8888-125-02	FDA UDI	Class II	Active
Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit	DEN180032	FDA 510(k)	Class II	Active
Leap Rheumatoid Factor Test Kit	K831941	FDA 510(k)	Class II	Active
Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit	K212204	FDA 510(k)	Class II	Active
Logix Smart ZDC (Zika, Dengue, Chikungunya)	ZDC-K-001	EUDAMED	IVD General	Active
Logix Smart ABC (Influenza A/B, SARS-Cov-2)	ABC-K-001	EUDAMED	IVD General	Active
Logix Smart MTB Test Kit	MTB-K-007	EUDAMED	IVD General	Active

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