Products/MALDI Biotyper Sirius System

MALDI Biotyper Sirius System

Bruker
510(k) ClearedCE-IVD

High-throughput microbial identification including Candida auris and filamentous fungi

Technical Specifications

PlatformMALDI-TOF MS
MultiplexNo
Target Count1
Sensitivity≥97%
Specificity≥99%
Turnaround Time10 min
Storage Temperature2–8°C
Shelf Life12 months

Pathogen Targets (2)

Candida auris· fungusAspergillus fumigatus· fungus

Sample Types

Bronchoalveolar lavage

Blood (whole)

Wound swab

Detection Methods

Flow Cytometry

Regulatory Status

FDA510(k) Cleared

K201234

510(k)

8/1/2020

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $3–$10

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.