Accurate data where it matters, so you can act now.
Wide access to polymerase chain reaction (PCR) based, JIT testing enables instant mobility, appropriate treatments, and surveillance.
Trusted PCR performance, JIT – Just in Time.
The Accula System has received FDA Emergency Use Authorization (EUA) for SARS-CoV-2 (the virus responsible for COVID-19) in vitro diagnostic testing. It is available now for use in patient care settings.
Easy and fast, our qualitative PCR-based test provides visual results within ~ 30 minutes.
The Accula SARS-CoV-2 Test has not been FDA cleared or approved; it has been authorized by FDA under an EUA for use by CLIA-certified laboratories that meet requirements to perform high, moderate or waived complexity tests. It is also 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 Accula SARS-CoV-2 Test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. §360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
How our technology works
We offer PCR-based tests on the Accula™ System for Flu A/B and RSV in addition to our SARS-CoV-2 test. The Accula System has received EUA for SARS-CoV-2, the virus responsible for COVID-19.
Accula Flu A/Flu B
The Accula System has received Emergency Use Authorization for SARS-CoV-2 (the virus responsible for COVID-19). The Accula Flu A/Flu B and the Accula RSV tests have obtained CE mark in the EU, and 510(k) clearance and Clinical Laboratory Improvements Amendments (CLIA) waiver from the US Food and Drug Administration (FDA).