MoFi Cell Culture Basal Medium
by Duogenic Stemcells Corporation 510(k)
Active
510(k) K240247
Overview
MoFi Cell Culture Basal Medium is a tissue culture media for human ex vivo tissue and cell culture processing. It is classified as a Class 2 device under regulation number 21 CFR 876.5885 with product code NDS.
The device received FDA 510(k) clearance (K240247) through the Traditional pathway on July 12, 2024, and is manufactured by Duogenic Stemcells Corporation in Taichung City, Taiwan. It is intended for use in gastroenterology and urology applications as part of ex vivo tissue and cell culture workflows.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK240247 | Date12 Jul 2024 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 25 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NDS
- Device Class
- Class II
- Regulation
- 21 CFR Part 876.5885
- Advisory Committee
- Gastroenterology, Urology
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the MoFi Cell Culture Basal Medium used for?
The MoFi Cell Culture Basal Medium is intended for human ex vivo tissue and cell culture processing, specifically supporting workflows in gastroenterology and urology applications as part of tissue culture procedures.
How is the MoFi Cell Culture Basal Medium supplied and is it sterile?
The device data does not specify the supply format or sterility status of the MoFi Cell Culture Basal Medium; therefore, details about its packaging, delivery form, or sterility cannot be determined from the provided information.
Is the MoFi Cell Culture Basal Medium reusable or single-use?
The provided device data does not indicate whether the MoFi Cell Culture Basal Medium is designed for single-use or reuse, so no conclusion can be drawn about its reusability based on the available specifications.
What regulatory pathway was used for the MoFi Cell Culture Basal Medium?
The MoFi Cell Culture Basal Medium received FDA 510(k) clearance through the Traditional pathway, as indicated by the clearance_type field in the device data, with decision date July 12, 2024, under K240247.