Lab industry groups hope to change CMS's controversial 2016 decision allowing nurses to perform complex lab tests.
The Xpert Xpress Flu can detect both influenza A and B virus in 20 minutes from either nasopharyngeal or nasal swabs.
The firm's Group A Strep test for use on its Sofia2 analyzer also received CLIA waiver from the agency.
The new draft guidance is expected to reduce study-related costs and save time for manufacturers of certain classes of in vitro devices.
The firm has secured NYS approval for its sequencing-based 32-gene Fertilome assay, which it originally launched in January.
The XW-100 Automated Hematology Analyzer previously received 510(k) clearance. With the CLIA waiver, the test can be run in more types of healthcare facilities.
The test, the fourth Zika serological assay available under EUA, qualitatively detects Zika virus IgM antibodies in human serum and plasma.
The company's Hong Kong laboratory was established in 2010 and was accredited by the College of American Pathologists in 2013.
The firm plans to launch its first test from the lab, a mRNA-based noninvasive confirmatory lung diagnostic, by the end of this year.
The deal includes mainly Siemens' customer's sales and distribution contracts, the installed instrument base, and relevant intellectual property.