Products/Meridian Illumigene C. difficile

Meridian Illumigene C. difficile

Meridian Bioscience
510(k) ClearedCE-IVD

LAMP-based detection of C. difficile toxin genes from stool specimens

Technical Specifications

Platformillumipro-10
MultiplexNo
Target Count1
Sensitivity≥95%
Specificity≥97%
Turnaround Time1 hr
Storage Temperature15–30°C
Shelf Life18 months

Pathogen Targets (1)

Clostridioides difficile· bacteria

Sample Types

Stool/Feces

Detection Methods

LAMP

Regulatory Status

FDA510(k) Cleared

K101234

510(k)

6/1/2011

EMA / CE-IVDCE-IVD

Class: Class C

Pricing

USD $15–$28

Per per test

Source: estimate · Confidence: 70%

Pricing is estimated. Contact manufacturer for current pricing.