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Parker Quality & Compliance

PQC Reg Watch

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Device type

Qualitative Cleaning Process Protein Indicator

Product code SDC · Class II · 21 CFR 880.6930 · General Hospital

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.

FDA classification database

Recent 510(k)s

Recent recalls