Products/BioFire® Joint Infection (JI) Panel
Multiplex

BioFire® Joint Infection (JI) Panel

BioFire Diagnostics, LLC
510(k) ClearedCE-IVD

Qualitative detection of gram-positive bacteria, gram-negative bacteria, and yeast from synovial fluid specimens

Technical Specifications

PlatformFilmArray
MultiplexYes
Target Count31
Sensitivity95.8
Specificity99
Turnaround Time1 hr
Storage Temperature2–25°C
Shelf Life12 months

Pathogen Targets (4)

Staphylococcus aureus· bacteriaEscherichia coli· bacteriaCandida albicans· fungusStreptococcus agalactiae· bacteria

Sample Types

Synovial Fluid

Detection Methods

PCR

Regulatory Status

FDA510(k) Cleared

K220123

510k

6/15/2022

Class: Class II

Source
EMA / CE-IVDCE-IVD

CE 0459

CE-IVD

11/1/2022

Class: Class C

Source

Pricing

USD $150–$200

Per per test

Source: procurement · Confidence: 75%

Source

Pricing is estimated. Contact manufacturer for current pricing.