Mologic Malaria P.f/P.v RDT

510(k) ClearedCE-IVD

Rapid detection of P. falciparum and P. vivax antigens from whole blood

Technical Specifications

PlatformLateral Flow

MultiplexYes

Target Count2

Sensitivity≥95%

Specificity≥97%

Turnaround Time20 min

Storage Temperature2–30°C

Shelf Life24 months

Blood (whole)

Antigen RDT

Lateral Flow Immunoassay

FDA510(k) Cleared

K201890

510(k)

11/1/2020

EMA / CE-IVDCE-IVD

Class: Class B

USD $1–$4

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.