Products/Unyvero HPN Hospitalized Pneumonia Panel
Multiplex

Unyvero HPN Hospitalized Pneumonia Panel

Curetis (OpGen)
510(k) ClearedCE-IVD

Detection of 21 pathogens and 17 resistance markers from BAL and other respiratory specimens

Technical Specifications

PlatformUnyvero
MultiplexYes
Target Count21
Sensitivity≥88%
Specificity≥95%
Turnaround Time5 hr
Storage Temperature2–8°C
Shelf Life18 months

Pathogen Targets (5)

Staphylococcus aureus· bacteriaMRSA· bacteriaKlebsiella pneumoniae· bacteriaPseudomonas aeruginosa· bacteriaAcinetobacter baumannii· bacteria

Sample Types

Bronchoalveolar lavage

Sputum

Detection Methods

Multiplex PCR

Regulatory Status

FDA510(k) Cleared

K202456

510(k)

12/1/2020

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $200–$280

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.