HOLISTIC, SCIENCE BASED DIETARY SUPPLEMENTS & IVD MEDICAL DEVICES

A LATERAL FLOW TEST GLOBAL LEADER

DEVELOPING THE WORLD’S MOST ACCURATE &
DURABLE LATERAL FLOW DEVICES

CURRENTLY DEVELOPING A LATERAL FLOW TEST KIT FOR THE DETECTION OF
VIRAL SHEDDING

– About us

THE HIGHEST BENCHMARK IN MEDICAL

DEVICE PERFORMANCE

• RESEARCH AND DEVELOPMENT

• Producing the World’ Most Accurate & Durable Lateral Flow Devices (IVDs) to enable unrestricted use outside of climate controlled facilities, particularly in limited resource settings is North American Diagnostics’, “NAD” mantra. We enjoy building durable, accurate, resilient, robust and scalable lateral flow immunoassay (LFIA) based rapid diagnostic tests (RDTs) at affordable pricing to truly open and equitize global healthcare access. North American Diagnostics strives to create an affordable, and sustainable test platform for all health systems globally – quality products to battle not only SARS, but other zoonotic diseases.

• We are a trusted partner to laboratories in the United States and public health agencies and organizations globally, such as Africa.

• We develop durable, accurate, resilient and mass scalable lateral flow tests at affordable pricing to prevent the typical barriers which are inherent from first world to third world implementation. Our scientific resources and capacity are sustainable into any global healthcare system

• – PRODUCT INFORMATION

PLEASE DON’T HESITATE TO REACH OUT TO US FROM ANY CORNER OF THE WORLD.

JOIN THE NORTH AMERICAN lateral flow
HEALTH & WELLNESS MOVEMENT.

Experienced with 21 CFR, Investigational New Drug Application (IND), Code of Federal Regulations (CFR), US Public Law 110-85, EUA applications for HCP Rx and OTC – SARS-CoV-2 Antigen, Point-of-Care (POC) regulations and 510k/PMK, CLSI EP25-A and ISO 23640:2011

• RESEARCH AND DEVELOPMENT

• RESEARCH AND DEVELOPMENT

If you require clinical studies with IRB approvals, we can arrange all aspects from protocol and ICF generation, IRB approval, site selection, site implementation, monitoring visits, spot audits, professional paper generation, publishing into peer review publications and subsequent press releases.

– THE MISSION

THE TRUE VALUE
OF INNOVATION

We not only strive to develop the most accurate in vitro devices to market, but ensure that tremendous value objectives are met for end users. We ensure that the demands placed on our business partners are met by us no matter what.

November 30, 2021

USA based clinical trials for Lateral Flow are initiated towards Emergency Use Authorization with the U.S. Food & Drug Administration

The world’s most accurate SARS-CoV-2

3 to 20 Minute Rapid Antigen Test

– THE MISSION

Continued R&D to HELP LEAD THE FIGHT not only AGAINST COVID-19 but other zoonotic diseases

We certainly have made a dramatic impact in Zoonotic R&D. A challenge as complex as the Covid-19 pandemic required North American Diagnostics to enter the arena with not only innovative, but adaptable solutions driven by the demands generated and sought by the actual end user. To meet the need for accurate, reliable screening, we have a suite of products that includes PCR, serology, and antigen testing.

OUR WORK HAS JUST BEGUN

As we look toward the future and beyond, North American Diagnostics not only merely responds to the changing environment, but moves forward with a proactive stance pushing the envelope of science with deliverable affordable and ground breaking medical devices. 

With a slow and self-funded growth, a small company has produced results that only top medical device companies in the world have accomplished. We will continue to develop next-generation technologies and sustain growth. As a relatively new, medical diagnostic firm, North American Diagnostics is committed in promoting hope for a healthy life and garnering the trust of the both the medical community and people.

World Headquarters

Daytona Beach, Florida, USA

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Read about our new product releases and events, and learn more about how our R&D products are helping to fight disease all over the world.