Product code NDS
- Device name
- Media, Culture, Ex Vivo, Tissue And Cell
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.5885
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232543 | MSC SFM | Yocon Biology Technology Company | 2024-09-06 |
| K240247 | “MoFi” Cell Culture Basal Medium | Duogenic Stemcells Corporation | 2024-07-12 |
| K231804 | PRIME-XV FreezIS DMSO-Free MD | Fujifilm Irvine Scientific | 2023-11-09 |
| K201789 | CT-STOR | Energy Delivery Solutions | 2021-09-20 |
| K113566 | OPTMIZER CTS T-CELL EXPANSION SERUM FREE MEDIUM | Life Technologies, Inc. | 2012-06-21 |
| K103302 | STEMPRO MSC SFM | Life Technologies Corporation | 2011-02-18 |
| K100616 | KNOCKOUT SR MEDIUM, KNOCKOUT SR XENOFREE MEDIUM MODEL 10828, 12618 | Life Technologies Corporation | 2010-05-20 |
| K022086 | AIM-V (R) MEDIUM, MODEL 087-0112 | Invitrogen Corporation | 2002-12-23 |
| DEN000008 | DULBECCO'S MODIFIED EAGLE MEDIUM (DMEM) | Life Technologies, Inc. | 2001-02-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05407010122848 | TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1L | Lonza Verviers | 2022-09-12 |
| 05407010122831 | X-VIVO 10 w/o Gentamycin w/o PR, 1L | Lonza Verviers | 2022-09-12 |
| 05407010122824 | TheraPEAK X-VIVO10(04-743) contains rec transf -1L | Lonza Verviers | 2022-09-12 |
| 05407010122817 | TheraPEAK™ X-VIVO™ 15 w REC TRANSF 1L | Lonza Verviers | 2022-09-12 |
| 05407010122756 | X-VIVO 15 w/o PR and Gentamicine 10L bag | Lonza Verviers | 2022-09-12 |
| 05407010122589 | X-VIVO 15 w/o Gentamycin and PR - 3L bag | Lonza Verviers | 2022-09-12 |
| 05407010122572 | X-Vivo10 w/o Gent, PR w/ Rec Transf, 10L | Lonza Verviers | 2022-09-12 |
| 05407010122565 | STD X-Vivo 15 w/o gentamicin and pr, 1L | Lonza Verviers | 2022-09-12 |
| 05407010122657 | X-VIVO 10 w/o Gentamycin w/o PR 1L | Lonza Verviers | 2022-09-06 |
| 05407010122640 | X-VIVO10(04-743) contains rec transf -1L | Lonza Verviers | 2022-09-06 |
| 05407010122633 | X-Vivo15(04-744) contains rec transf, 1L | Lonza Verviers | 2022-09-06 |
| 05407010122626 | X-Vivo15(04-744)contains rec tran 1L bag | Lonza Verviers | 2022-09-06 |
| 05407010122558 | STD X-Vivo 15 w/o gentamicin and pr, 5L | Lonza Verviers | 2022-09-06 |
| 05407010122541 | X-Vivo 15 w/o gentamicin and pr, 5L | Lonza Verviers | 2022-09-06 |
| 10190302014274 | CTS™ OpTmizer™ T-Cell Expansion Basal Medium | LIFE TECHNOLOGIES CORPORATION | 2018-06-15 |
| 10190302014250 | CTS™ AIM-V™ Medium | LIFE TECHNOLOGIES CORPORATION | 2018-04-13 |
| 10190302000543 | DMEM (1X) Dulbecco's Modified Eagle Medium | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002356 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002349 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002158 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002141 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002110 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002103 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002097 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302002042 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001502 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001496 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001472 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001434 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |
| 10190302001229 | DMEM (Dulbecco's Modified Eagle Medium) | LIFE TECHNOLOGIES CORPORATION | 2016-08-01 |