- Physicians Office Resource

IVD reagent kit containing 30 kits.
BioFire® Joint Infection (JI) Panel - RFIT-ASY-0138

Device Description

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (e.g., bacteria, viruses, parasites) associated with osteoarticular/joint infection in a clinical specimen (typically synovial fluid), using a nucleic acid technique (NAT). This test detects pathogens which may include Clostridium, Klebsiella, and Salmonella bacteria, and the yeast Candida albicans, and is used to aid the diagnosis of infectious arthritis (septic arthritis) and/or prosthetic joint infection.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: QSN

Device Name: Orthopedic Infection Microbial Multiplex Nucleic Acid Detection System

Device Class: 2

Physical State: In vitro diagnostic device consisting of reagents and associated instrumentation for the detection of microorganism nucleic acid sequences and resistance markers in clinical specimens.

Definition: A qualitative nucleic acid assay that detects and identifies microbial organisms and antimicrobial resistance markers in clinical specimens to aid in the diagnosis of orthopedic infections.

Submission Type ID: 1

Review Panel: MI

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Multiplexed nucleic-acid assay

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Clinical specimens from patients suspected of orthopedic infection

Regulation Number: 866.3988

Third Party Flag: N

Medical Specialty: MI

Device Identifiers

Device Id: 00815381020192

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The information provided on this site includes data supplied by The GMDN Agency ("GMDN Content"), which is used under licence from The GMDN Agency. Any data/information suppliers who wish to extract GMDN Content from this site in order to use it as a basis for creating and supporting commercial services such as alternative categorisation, alternative GMDN Term assignment, mapping to other categorisations or ontologies, or for AI training purposes, must first obtain an appropriate licence from The GMDN Agency. No such activity is permitted without a licence. For more information on obtaining a licence, please contact The GMDN Agency (https://www.gmdnagency.org/contact-us/). None of the GMDN content constitutes any endorsement, advice, representation or warranty about any specific medical devices that may be described by such content; and no representation or warranty is made in relation to instructions for use, suitability for any application, treatment or condition, regulatory status, or any properties of a particular medical device.