Product code OEM— Microbiology

“A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in conjunction with other clinical and laboratory testing in patients exhibiting signs and symptoms of upper respiratory tract infections.”

FDA has cleared 6 devices under product code OEM between 2008 and 2023, 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.

• 20231 clearance
• 20133 clearances
• 20111 clearance
• 20081 clearance

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

• K230349 — Lyra RSV+hMPV AssayQuidel Corporation·2023-03-10
• K132200 — PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.·2013-08-14
• K122189 — QUIDEL MOLECULAR RSV + HMPV ASSAYQuidel Corp.·2013-03-08
• K123838 — PRO HMPV+ ASSAYGen-Probe Prodesse, Inc.·2013-01-16
• K112490 — QUIDEL MOLECULAR HMPV ASSAYQuidel Corp.·2011-12-15
• K082688 — PRO HMPV+ ASSAYProdesse, Inc.·2008-11-07