Products/MALDI Biotyper CA System

MALDI Biotyper CA System

Bruker
510(k) ClearedCE-IVD

Identification of bacteria and fungi from isolated colonies using MALDI-TOF mass spectrometry

Technical Specifications

PlatformMALDI-TOF MS
MultiplexNo
Target Count1
Sensitivity≥95%
Specificity≥99%
Turnaround Time15 min
Storage Temperature2–8°C
Shelf Life12 months

Pathogen Targets (4)

Staphylococcus aureus· bacteriaCandida auris· fungusKlebsiella pneumoniae· bacteriaPseudomonas aeruginosa· bacteria

Sample Types

Blood (whole)

Wound swab

Detection Methods

Flow Cytometry

Regulatory Status

FDA510(k) Cleared

K143010

510(k)

1/1/2015

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $2–$8

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.