NDS · Media, Culture, Ex Vivo, Tissue And Cell
Gastroenterology, Urology · 21 CFR 876.5885 · Class 2
Overview
| Product Code | NDS |
|---|---|
| Device Name | Media, Culture, Ex Vivo, Tissue And Cell |
| Regulation | 21 CFR 876.5885 |
| Device Class | Class 2 |
| Review Panel | Gastroenterology, Urology |
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.
Classification Rationale
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.”
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.”
Cleared Devices (9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K232543 | MSC SFM | Yocon Biology Technology Company | Sep 6, 2024 | SESE |
| K240247 | MoFi Cell Culture Basal Medium | Duogenic Stemcells Corporation | Jul 12, 2024 | SESE |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific | Nov 9, 2023 | SESE |
| K201789 | CT-STOR | Energy Delivery Solutions | Sep 20, 2021 | SESE |
| K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | Life Technologies, Inc. | Jun 21, 2012 | SESE |
| K103302 | STEMPRO MSC SFM | Life Technologies Corporation | Feb 18, 2011 | SESE |
| K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 | Life Technologies Corporation | May 20, 2010 | SESE |
| K022086 | AIM-V (R) MEDIUM, MODEL 087-0112 | Invitrogen Corporation | Dec 23, 2002 | SESE |
| DEN000008 | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | Life Technologies, Inc. | Feb 16, 2001 | DENG |
Top Applicants
- Life Technologies, Inc. — 2 clearances
- Life Technologies Corporation — 2 clearances
- Yocon Biology Technology Company — 1 clearance
- Invitrogen Corporation — 1 clearance
- Fujifilm Irvine Scientific — 1 clearance
