Products/BioFire® Blood Culture Identification 2 (BCID2) Panel
Multiplex

BioFire® Blood Culture Identification 2 (BCID2) Panel

BioFire Diagnostics, LLC
510(k) ClearedCE-IVD

Qualitative detection and identification of blood culture isolates including bacteria, yeast, and resistance markers

Technical Specifications

PlatformFilmArray
MultiplexYes
Target Count43
Sensitivity97.8
Specificity99.7
Turnaround Time1 hr
Storage Temperature2–25°C
Shelf Life12 months

Pathogen Targets (7)

Streptococcus pneumoniae· bacteriaStaphylococcus aureus· bacteriaKlebsiella pneumoniae· bacteriaPseudomonas aeruginosa· bacteriaEnterococcus faecalis· bacteriaEscherichia coli· bacteriaCandida albicans· fungus

Sample Types

Blood/Serum

Detection Methods

PCR

Regulatory Status

FDA510(k) Cleared

K202345

510k

8/26/2020

Class: Class II

Source
EMA / CE-IVDCE-IVD

CE 0459

CE-IVD

5/26/2021

Class: Class C

Source

Pricing

USD $150–$200

Per per test

Source: procurement · Confidence: 75%

Source

Pricing is estimated. Contact manufacturer for current pricing.