FDA product code SDC

Qualitative Cleaning Process Protein Indicator

General Hospital·Class 2·21 CFR 880.6930
US regulatory classifications
US Product Code (FDA)
SDC
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.6930
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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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About this record

Qualitative Cleaning Process Protein Indicator is a medical device type in the General Hospital specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.