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Snibe Diagnostic Receives CE Mark for SARS-CoV-2 Kits, Immunoassay System

NEW YORK – Shenzhen, China-based Snibe Diagnostic announced Friday it has received CE marking for its Maglumi 2019-nCoV (SARS-CoV-2) IgM/IgG kits, which are currently being used by hospitals in China and will soon be available to hospitals in Italy. The first batch of reagent kits were distributed to several key hospitals in China during the past few weeks, Snibe said.

With rapid detection and high specificity, the 2019-nCoV IgG/IgM kits ─ having passed rigorous clinical verification in China ─ can help labs and hospitals with early diagnosis and elimination of suspicious cases, the company said.

Snibe further announced that its Maglumi X8 chemiluminescence immunoassay system has received CE marking. Maglumi X8 has a maximum throughput of 600 tests per hour, on-board capacity of 300 samples, and operates in random access or batch mode, the company said.