IVD reagent kit containing 30 kits.

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

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.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 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