Offer your patients rapid PCR testing with results in ~30 minutes

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The Thermo Fisher Scientific Accula system is a rapid diagnostic point of care platform that provides simple, accurate sample-to-answer rapid PCR. Using a palm-sized Accula Dock in a CLIA waived environment, the Accula rapid PCR Tests provide reliable, qualitative PCR results in ~30 minutes.

NOTE: Your organization will need to provide a CLIA Certificate of waiver before orders will be fulfilled.

Accula test products have not been approved for at-home use and will not ship to individuals for personal testing. Please visit our Find a PCR Test Near Me page if you are trying to locate a local testing location.

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 Flu A/B
 RSV
 SARS-CoV-2
 Strep A
 Other
 
 Yes
 No
 
 Yes
 No
 
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NOTE: Testing for the Accula SARS-CoV-2 Test is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The Accula SARS-CoV-2 Test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation..

 To the best of my knowledge, the organization I represent has a CLIA Certificate of Waiver or plans on getting the certification in the near future.
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This test has not been FDA cleared or approved but has been authorized for emergency use by the FDA for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

For Emergency Use Authorization (EUA) Only. For prescription use only. For in vitro diagnostic use.