- North American Diagnostics

a global Leader

PRODUCING THE WORLD'S MOST ACCURATE & DURABLE LATERAL FLOW DEVICES

BACKED BY ROBUST CLINICAL STUDIES

- About Us

THE HIGHEST BENCHMARK IN MEDICAL

DEVICE PERFORMANCE

RESEARCH AND DEVELOPMENT

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

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’ 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’ has created an affordable, and sustainable test platform for all health systems globally – quality products to battle not only COVID-19, but many serious diseases.

We are a trusted partner to many laboratories in the United States and public health agencies and organizations around the world. 

We build 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 

RESEARCH AND DEVELOPMENT

RESEARCH AND DEVELOPMENT

- PRODUCT INFORMATION

PLEASE DONT HESITATE TO REACH OUT TO US FROM ANY CORNER OF THE WORLD.

Join The North American Diagnostics
Health & wellness movement.

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 bring the most accurate in vitro devices to market, but ensure that tremendous value objectives are met for our clients and the end users. We ensure that the demands placed on our business partners are met by us no matter what.

We have had to increase production levels for our ODM and OEM clients to a launch capacity of 5 million units first month, 3 month spike capacity to 18 million, 36 million and 72 million units with global capacity to 250 million units over a 4 month timeline.

November 30, 2021

North American Diagnostics launches the world’s most accurate SARS-CoV-2 20 Min Antigen Test

- THE MISSION

Q3 2021 will be the time we now HELP lead the FIGHT AGAINST COVID-19

But we certainly have made a dramatic impact mid 2021. 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. 

Bein With a slow and self-funded growth despite the odds, a small company has produced results that only the Top 5 medical device companies in the world accomplished. We will continue to develop next-generation technologies and sustain growth. As a new world leader in medical diagnosis, North American Diagnostics is committed in promoting hope for a healthy life and garnering the trust of the both the medical community and people.

Thank you.

Paul Singh & Michael Membrino

world headquarters
Daytona Beach, Florida, USA

STAY UP TO DATE

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