• COVID-19 Testing Solutions, Made in America

Rapid Antigen LDT Tests

Our Product

Rapid Antigen Tests

No CLIA waiver? No problem! This lab developed test is paired with Rymedi’s software platform Now, nurses, dentists, long-term care facilities, pharmacists, corporate clients can conduct testing, while maintaining compliance with state and federal guidelines. Our platform is ideal for private practices, specialty providers, dermatologists, plastic surgeons, rehabilitation centers, and more!

Finally... Reliable Rapid Antigen Testing is Now Available for Everyone!

  • No machines! Results in 15 Minutes
  • Asymptomatic or symptomatic testing
  • Highly sensitive and specific
  • Nasopharyngeal swab + lateral flow assay
  • Made in America
  • Not intended for home use
  • $25 per Unit (20 Units per Package)
  • Please allow 2-3 Business Days for Shipping
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Our Free Software Ensures Compliant Use of Rapid Antigen LDTs

  • Will automatically report results to public health entities
  • Provides CLIA oversight in real-time
  • Secure, HIPAA compliant system
  • Patients can access results on their smartphones
  • Ideal for multi-site testing programs
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Keep Your Customers and Employees Safe from COVID-19

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Notices About This Product

  • This product has not been reviewed by the FDA. On August 19, 2020, HHS announced a rule change that FDA will no longer require premarket review of laboratory-developed tests (LDTs), including tests for COVID-19.
  • LDTs may now be marketed and used without an FDA Emergency Use Authorization (EUA) so long as the tests are used in compliance with all requirements under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and any additional state specific laws.
  • LDTs are intended for point of care application, they are not intended for home use without clinician, provider or lab oversight to interpret test results. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Frequent testing is recommended. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
  • Results from one rapid test should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Those who receive negative results should still continue to follow physical safety protocol to avoid exposure. For those with positive results, isolation and follow-up testing is recommended. Consider follow up testing with molecular diagnostic to rule out infection in these individuals.
  • Additional information including clinical validation studies, fact sheets, and supplemental information available upon request.
  • Report All Adverse events, including problems with test performance or results, by submitting the online FDA Form 3500 or by calling 1-800-FDA-1088.
  • All information, content, trademarks, service marks and logos are protected by copyright, trademark laws and various other intellectual property rights and unfair competition laws of the United States, foreign jurisdictions, and international conventions. Reproduction and distribution of this material without written authorized consent from Acumen Diagnostics Inc is strictly prohibited.