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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device qualitative cleaning process protein indicator
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.
Product CodeSDC
Regulation Number 880.6930
Device Class 2


Premarket Reviews
ManufacturerDecision
STERIS
  GRANTED 1

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