Product code NZB— Microbiology

“Dna quality control material for genetic testing is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. This type of device includes synthetic dna controls and cell-line based controls.”

FDA has cleared 4 devices under product code NZB between 2006 and 2010, filed by 3 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.

• 20101 clearance
• 20081 clearance
• 20062 clearances

• Maine Molecular Quality Controls, Inc.2 clearances
• Instrumentation Laboratory CO1 clearance
• Gentris Corporation1 clearance

• K093737 — HEMOSIL F11 & FV DNA CONTROLInstrumentation Laboratory CO·2010-05-04
• K083171 — INTROL CF PANEL I CONTROL, MODEL: G106Maine Molecular Quality Controls, Inc.·2008-12-16
• K063224 — GENTRISURE HUMAN GENOMIC DNA REFERENCE CONTROLGentris Corporation·2006-12-22
• DEN060007 — INTROL CF PANEL I CONTROLMaine Molecular Quality Controls, Inc.·2006-10-12