Product code OOU— Microbiology

“A parainfluenza multiplex nucleic acid assay is a multiplex in vitro diagnostic test for the simultaneous qualitative detection and discrimination of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus nucleic acids isolated and purified from human respiratory specimens obtained from individuals exhibiting signs and symptoms of respiratory tract infections or viral culture. The detection and discrimination of human parainfluenza nucleic acids from symptomatic patients aid in the diagnosis of human respiratory tract parainfluenza infections if used in conjunction with other clinical and laboratory findings.”

FDA has cleared 5 devices under product code OOU between 2009 and 2017, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20171 clearance
• 20151 clearance
• 20141 clearance
• 20131 clearance
• 20091 clearance

• Hologic, Inc.2 clearances
• Quidel Corporation1 clearance
• Prodesse, Inc.1 clearance
• Gen-Probe Prodesse, Inc.1 clearance

• K172282 — Panther Fusion Paraflu AssayHologic, Inc.·2017-10-23
• K153223 — ProParaFlu+ AssayHologic, Inc.·2015-12-09
• K141927 — LYRA PARAINFLUENZA VIRUS ASSAYQuidel Corporation·2014-10-09
• K132238 — PROPARAFLU+ ASSAYGen-Probe Prodesse, Inc.·2013-08-26
• K091053 — PROPARAFLU+ASSAYProdesse, Inc.·2009-11-20