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Medical Devices; Immunology and Microbiology Devices; Classification of Clostridium Difficile Toxin Gene

Federal Register

|August 29, 2015

Abstract:

The Food and Drug Administration (FDA) is classifying Clostridium difficile (C. difficile) toxin gene amplification assay into class II (special controls). The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

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Real Time RT-PCR

Real Time RT-PCR

Real-time reverse transcription-polymerase chain reaction, or Real-time RT-PCR, is an analytical tool used to determine the expression level of target genes. The method involves converting mRNA to complementary DNA with the help of an enzyme known as reverse transcriptase, followed by the PCR amplification of the cDNA. These two processes can be performed simultaneously in a single tube or separately as a two-step reaction.
The real-time quantification of the number of amplified products is...

Articles linked to this work by shared authors, journal, and citation graph.

Erratum: Findings of Research Misconduct; Correction.

Federal register·2023

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