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Panther Fusion Open Access is a non-IVD function that is not required to have FDA clearance or approval.

 

1. Panther Fusion GBS assay [US package insert]. AW-17997, Rev. 001. San Diego, CA: Hologic, Inc.; 2018.  2. CDC. Prevention of Perinatal Group B Streptococcal Disease: Revised Guidelines from CDC, 2010. MMWR. 2010;59:RR-10.  3. Xpert GBS LB [package insert]. 301-0576, Rev. 05. Sunnyvale, CA: Cepheid; 2014.  4. BD Max GBS assay [package insert]. P0091, Rev. 05. Franklin Lakes, NJ: Beckton, Dickson and Company; 2012.  5. AmpliVue GBS assay [package insert]. Athens, OH: Quidel Corporation; 2013.  6. ARES GBS assay [package insert]. 89-30000-00-486, Rev. B. Austin, TX: Luminex Corporation; 2016.  7. illumigene Group B Streptococcus assay [package insert]. SN11181. Cincinnati, OH: Meridian Bioscience, Inc.; 2016.

 

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