illumigene Mycoplasma Direct

Primary DI

00840733101274

Brand

illumigene Mycoplasma Direct

Company

MERIDIAN BIOSCIENCE, INC.

Model

280250

Catalog number

280250

Device description

The illumigene Mycoplasma Direct DNA amplification assay, performed on the illumipro-10, is a qualitative in vitro diagnostic test for the direct detection of DNA from Mycoplasma pneumoniae in human throat swabs obtained from patients suspected of having Mycoplasma pneumoniae infection. The illumigene Mycoplasma Direct assay utilizes loop-mediated isothermal DNA amplification (LAMP) technology to detect Mycoplasma pneumoniae by targeting a segment of the Mycoplasma pneumoniae genome. Results from the illumigene Mycoplasma Direct DNA amplification assay should be used in conjunction with clinical presentation, other laboratory findings, and epidemiological risk factors as an aid in the diagnosis of Mycoplasma infection and should not be used as the sole basis for treatment or other patient management.

Published

2016-09-23

Public version status

Update

Distribution status

Not in Commercial Distribution

MRI safety

Labeling does not contain MRI Safety Information

Rx

true

Single use

true