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NEW YORK – Sysmex announced on Friday that it has received in vitro diagnostic approval for manufacturing and marketing of its HISCL Influenza Assay Kit in Japan. 

The chemiluminescence enzyme immunoassay detects influenza A/B antigens from nasopharyngeal or nasal swabs and is used on the firm's HISCL-5000/HISCL-800 automated immunoassay analyzers, the company said in a statement. The HISCL-5000 returns results in 17 minutes and processes 200 tests an hour. Sysmex also received insurance coverage for the test, which is expected to launch at the end of February. 

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