DeviceClearance

Product code SDC— General Hospital

VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator

Classification name
Qualitative Cleaning Process Protein Indicator
Device class
Class 2
Regulation
21 CFR 880.6930
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SDC under 21 CFR 880.6930, via openFDA

Market context for product code SDC

FDA has cleared 1 device under product code SDC, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SDC

Recent clearances under product code SDC

Data sourced from openFDA. This site is unofficial and independent of the FDA.