ITL BioMedical’s Cell Culture Sampler Listed with FDA as Class I Medical Device

The single-use device for controlled sampling from cell culture bags is now listed with the FDA as a Class I medical device under Product Code FMH.

Reston, VA—ITL BioMedical announced that its Cell Culture Sampler (CCS) is listed with FDA as a Class I medical device under Product Code FMH (21 CFR 864.3250) and is exempt from 510(k) premarket notification requirements. The device listing is associated with ITL Asia Pacific Sdn Bhd, ITL BioMedical’s manufacturing establishment.

The Cell Culture Sampler is a sterile, single-use device designed for small-volume sampling from cell culture bags into culture bottles without disconnecting the system. Dual air-vent syringes and a luer-activated valve support sample transfer, while a blue adapter cap fits common blood culture bottles. The device is designed to support aseptic technique and limit open handling during sampling.

"The Cell Culture Sampler reflects the same standard we hold for every device we bring to market: it needs to work exactly as labs expect, every time," said Craig Wilson, CEO of ITL BioMedical. "With the device now listed with FDA, we’re pleased to make it available to U.S. laboratories that need a practical, sterile option designed to support controlled, small-volume sampling."

The Cell Culture Sampler is available now to verified medical, laboratory, and veterinary accounts in the United States. Product details are available at itlbiomedical.com/cell-culture-sampler.html.

About ITL BioMedical

ITL BioMedical designs and manufactures biological sampling systems and healthcare devices for human and animal use. The company’s patented medical devices focus on safety and process efficiency for end users, their blood donors, and patients in blood collection centers and healthcare markets worldwide.

For more information or inquiries, visit ITLBioMedical.com.

Media Contact:

John Tonkinson, Ph.D.
Vice President of Global Sales and Marketing
+1 (703) 435-6700
John.Tonkinson@itlbiomedical.com