FDA Product Code NDS: Media, Culture, Ex Vivo, Tissue And Cell
Leading manufacturers include Life Technologies, Inc., Life Technologies Corporation and Invitrogen Corporation.
9
Total
8
Cleared
195d
Avg days
2001
Since
Declining activity -
0 submissions in the last 2 years
vs 3 in the prior period
FDA 510(k) Cleared Media, Culture, Ex Vivo, Tissue And Cell Devices (Product Code NDS)
9 devices
Cleared
Sep 06, 2024
MSC SFM
Yocon Biology Technology Company
Gastroenterology & Urology
381d
Cleared
Jul 12, 2024
“MoFi” Cell Culture Basal Medium
Duogenic Stemcells Corporation
Gastroenterology & Urology
164d
Cleared
Nov 09, 2023
PRIME-XV FreezIS DMSO-Free MD
Fujifilm Irvine Scientific
Gastroenterology & Urology
142d
Cleared
Sep 20, 2021
CT-STOR
Energy Delivery Solutions
Gastroenterology & Urology
447d
Cleared
Jun 21, 2012
OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM
Life Technologies, Inc.
Gastroenterology & Urology
202d
Cleared
Feb 18, 2011
STEMPRO MSC SFM
Life Technologies Corporation
Gastroenterology & Urology
101d
Cleared
May 20, 2010
KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618
Life Technologies Corporation
Gastroenterology & Urology
77d
Cleared
Dec 23, 2002
AIM-V (R) MEDIUM, MODEL 087-0112
Invitrogen Corporation
Gastroenterology & Urology
179d
Not Cleared
Feb 16, 2001
DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM)
Life Technologies, Inc.
Gastroenterology & Urology
59d
About Product Code NDS - Regulatory Context
510(k) Submission Activity
9 total 510(k) submissions under product code NDS since 2001, with 8 receiving FDA clearance (average review time: 195 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 3 in the prior period.