BioFire Diagnostics FilmArray Blood Culture Identification 2 (BCID2) Panel

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Available from:

BIOMERIEUX SINGAPORE PTE. LTD.

Class:

Class C IVD

Manufactured by:

BioFire Diagnostics, LLC

Therapeutic area:

Microbiology

Therapeutic indications:

The BioFire® Blood Culture Identification 2 (BCID2) Panel is a multiplexed nucleic acid test intended for use with BioFire® FilmArray® 2.0 or BioFire® FilmArray® Torch Systems for the simultaneous qualitative detection and identification of multiple bacterial and yeast nucleic acids and select genetic determinants associated with antimicrobial resistance. The BioFire BCID2 Panel test is performed directly on blood culture samples identified as positive by a continuous monitoring blood culture system. Results are intended to be interpreted in conjunction with Gram stain results. The BioFire BCID2 Panel is indicated as an aid in the diagnosis of specific agents of bloodstream infection and results should be used in conjunction with other clinical and laboratory findings. Positive results do not rule out co-infection with organisms not included in the BioFire BCID2 Panel. It is not intended to monitor treatment for bloodstream infection

Product summary:

Models: Biofire® BCID2 Panel - RFIT-ASY-0147

Authorization date:

2021-12-27