ITL BioMedical's Cell Culture Sampler Receives FDA Class I Medical Device Listing

AI-generated NewsSnap summary based on source reporting.
Published: 2026-09-15
Category: health
Source: ITL BioMedical

ITL BioMedical announced that its Cell Culture Sampler, a single-use device for controlled sampling from cell culture bags, has been listed with the FDA as a Class I medical device. This listing, under Product Code FMH, exempts the device from 510(k) premarket notification requirements, making it available to U.S. laboratories for aseptic, small-volume sampling.

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