QIAstat-Dx Meningitis/Encephalitis Panel

510(k) ClearedCE-IVD

Syndromic detection of 16 pathogens from CSF in suspected meningitis/encephalitis

Technical Specifications

PlatformQIAstat-Dx

MultiplexYes

Target Count16

Sensitivity≥92%

Specificity≥97%

Turnaround Time1 hr

Storage Temperature2–8°C

Shelf Life18 months

CSF

Multiplex PCR

FDA510(k) Cleared

K210987

510(k)

9/1/2021

EMA / CE-IVDCE-IVD

Class: Class C

USD $140–$200

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.