Products/DPP Syphilis Screen & Confirm

DPP Syphilis Screen & Confirm

Chembio Diagnostics
510(k) ClearedCE-IVD

Simultaneous treponemal and non-treponemal syphilis testing from whole blood

Technical Specifications

PlatformDPP (Dual Path Platform)
MultiplexNo
Target Count1
Sensitivity≥97%
Specificity≥97%
Turnaround Time15 min
Storage Temperature2–30°C
Shelf Life24 months

Pathogen Targets (1)

Treponema pallidum· bacteria

Sample Types

Blood (whole)

Serum

Detection Methods

Antibody RDT

Lateral Flow Immunoassay

Regulatory Status

FDA510(k) Cleared

K181234

510(k)

9/1/2018

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $4–$10

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.