DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
Device Facts
| Record ID | DEN000008 |
|---|---|
| Device Name | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) |
| Applicant | Life Technologies, Inc. |
| Product Code | NDS · Gastroenterology, Urology |
| Decision Date | Feb 16, 2001 |
| Decision | DENG |
| Submission Type | Post-NSE |
| Regulation | 21 CFR 876.5885 |
| Device Class | Class 2 |
Regulatory Classification
Identification
Tissue culture media for human ex vivo tissue and cell culture processing applications consist of cell and tissue culture media and components that are composed of chemically defined components (e.g., amino acids, vitamins, inorganic salts) that are essential for the ex vivo development, survival, and maintenance of tissues and cells of human origin. The solutions are indicated for use in human ex vivo tissue and cell culture processing applications.
Special Controls
*Classification.* Class II (special controls): FDA guidance document, “Class II Special Controls Guidance Document: Tissue Culture Media for Human Ex Vivo Processing Applications; Final Guidance for Industry and FDA Reviewers.”
