ALS obtains FDA registrations
ALS Life Sciences Portugal is registered since June 2021 as a manufacturer of medical devices, kits and oligonucleotides in the Food and Drugs Administration (FDA), the most important regulatory agency in the US. This registration allows the export of the abovementioned products to the US market and marks the first step of a long regulatory process.
On September 1, ALS registered the ALS SARS-CoV-2 RT-LAMP kit in the FDA as a Laboratory Developed Test (LDT), which authorizes the use of the in vitro diagnostics test in collaboration with a certified CLIA lab.
Currently, we are undertaking the activities required to obtain full FDA 510(K) and CLIA Waiver approvals.These approvals will allow the free introduction on the US market of medical devices for in vitro diagnostics produced in ALS Life Sciences Portugal and their use by any laboratory capable of carrying out diagnostic tests.
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