QVR — Multiplex Nucleic Acid Detection System For Biothreat Agents Class II

FDA Device Classification

Classification Details

Product Code: QVR
Device Class: Class II
Regulation Number: 866.4000
Submission Type
Review Panel: MI
Medical Specialty: Immunology
Implant: No

Definition

A multiplex nucleic acid detection system for biothreat agents is a qualitative in vitro diagnostic test for detection and identification of nucleic acids from biothreat pathogens in human clinical specimens

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K231336	t2biosystems	T2 Biothreat Panel	September 15, 2023
K213362	biofire defense	BioFire Global Fever Special Pathogens Panel; BIOFIRE SHIELD Control Kit for the	March 22, 2023