Product code OAH— Microbiology

AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KIT

Classification name: Fish (Fluorescent In Situ Hybridization) Kit, Protein Nucleic Acid, Enterococcus Faecalis
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Total cleared: 4
First cleared: 2006-12-22
Most recent: 2013-01-07

FDA classification definition

“E. Faecalis pna fish is a qualitative nucleic acid hybridization assay intended for the identification of enterococcus faecalis and other enterococci (oe) from blood cultures showing Gram-positive cocci in pairs and chains.”
— U.S. Food and Drug Administration, device classification record for product code OAH under 21 CFR 866.3740, via openFDA

Market context for product code OAH

FDA has cleared 4 devices under product code OAH between 2006 and 2013, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

20131 clearance
20092 clearances
20061 clearance

Top applicants under product code OAH

Advandx, Inc.4 clearances

Recent clearances under product code OAH

K121991 — ENTEROCOCCUS QUICKFISH BCAdvandx, Inc.·2013-01-07
K083074 — AVANDX E. FAECALIS/OE PNA FISH CULTURE IDENTIFICATION KITAdvandx, Inc.·2009-07-24
K082612 — GBS PNA FISHAdvandx, Inc.·2009-05-05
K063127 — ENTEROCOCCUS FAECALIS PNA FISHAdvandx, Inc.·2006-12-22

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