Product code NIJ— Microbiology

BD GENEOHM VANR ASSAY

Classification name: System, Test, Genotypic Detection, Resistant Markers, Enterococcus Species
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Total cleared: 6
First cleared: 2002-05-01
Most recent: 2024-11-21

FDA classification definition

“The in vitro device is intended to detect the presence of the vanA and vanB genes in isolated colonies of Enterococcus spp. as a marker for vancomycin resistance using DNA probe technology”
— U.S. Food and Drug Administration, device classification record for product code NIJ under 21 CFR 866.1640, via openFDA

Market context for product code NIJ

FDA has cleared 6 devices under product code NIJ between 2002 and 2024, filed by 5 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.

Clearances per year

20241 clearance
20131 clearance
20111 clearance
20091 clearance
20061 clearance
20021 clearance

Top applicants under product code NIJ

Cepheid®2 clearances
Intelligent Medical Devices, Inc.1 clearance
Id Biomedical Corp.1 clearance
Geneohm Sciences Canada, Inc.1 clearance
Bd Diagnostics Science1 clearance

Recent clearances under product code NIJ

K243405 — Xpert vanACepheid®·2024-11-21
K123753 — IMDX VANR FOR ABBOTT M2000Intelligent Medical Devices, Inc.·2013-07-17
K102416 — BD GENEOHM VANR ASSAYBd Diagnostics Science·2011-10-20
K092953 — Xpert VanA AssayCepheid·2009-12-17
K061686 — IDI-VANR ASSAYGeneohm Sciences Canada, Inc.·2006-08-30
K020576 — VELOGENE GENOMIC IDENTIFICATIONASSAY FOR VREId Biomedical Corp.·2002-05-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.