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FDA Issues Emergency Use Authorization for Maccura Biotechnology Coronavirus Test Kit

NEW YORK — The US Food and Drug Administration on Wednesday granted Emergency Use Authorization for Maccura Biotechnology's fluorescent PCR-based test kit for SARS-CoV-2.

The test is designed to detect nucleic acid from SARS-CoV-2 in upper respiratory specimens such as oropharyngeal swabs, nasopharyngeal swabs, nasal swabs, and midturbinate swabs. It includes qRT-PCR reaction mix, qRT-PCR enzyme mix, negative control materials, positive control materials, and internal control materials, as well as two nucleic acid extraction kits.

According to the FDA, the test can be run on any authorized RT-PCR instrument by a CLIA-certified lab.

Maccura is headquartered in Sichuan, China.

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