SDC

1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Qualitative Cleaning Process Protein Indicator

Device class

Class II (moderate risk)

Regulation

21 CFR 880.6930

Medical specialty

General Hospital

FDA definition

A qualitative cleaning process protein indicator is intended for use by a health care provider on a cleaned medical device as an interim step prior to high level disinfection or sterilization of the cleaned medical device. The intended use is to inform the health care user of the presence of residual soil protein in the sample extract.

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