KnockOut™ Serum Replacement
KnockOut Serum Replacement is a serum-free, defined medium for human tissue and cell processing outside the body. It supports the growth and maintenance of cells in culture, including…
KnockOut Serum Replacement is a serum-free, defined medium for human tissue and cell processing outside the body. It supports the growth and maintenance of cells in culture, including embryonic stem cells and patient-specific induced pluripotent stem cell lines.
The defined formulation is used in supplemented culture media to provide consistent growth conditions for cultured cells.
Storage
The liquid medium is aseptically processed. Its shelf life is 14 months when stored between 2 and 8 degrees Celsius.
Who Else Makes It
Registered in Beijing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Yocon Biology Technology Company | Haidian | Beijing | Manufacturer | 2 |
Record
| Listed by | Life Technologies Corporation, United States |
|---|---|
| FDA product code | NDS |
| Device type | Media, Culture, Ex Vivo, Tissue And Cell |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5885 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K100616 |
| Record published | 2016-08-01 |
| Record revised | 2020-08-10 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 10 |
| Distribution end date | 2020-08-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10828010 | Withdrawn | |
| 10828028 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dmem (Dulbecco’s Modified Eagle Medium) | Life Technologies Corporation | 24 |
| Gibco® CTS™ AIM V® SFM | Life Technologies Corporation | 2 |
| OpTmizer™ CTS™ T-Cell Expansion Basal Medium | Life Technologies Corporation | 2 |
| Gibco | Life Technologies Corporation | 2 |
| KnockOut™ SR Xenofree CTS™ | Life Technologies Corporation | 2 |
| CTS™ AIM-V™ Medium | Life Technologies Corporation | 2 |
| CTS™ OpTmizer™ T-Cell Expansion Basal Medium | Life Technologies Corporation | 2 |
| CTS™ OpTmizer™ T-Cell Expansion Supplement | Life Technologies Corporation | 1 |
| Stemproò MSC SFM Basal Medium CTS™ | Life Technologies Corporation | 1 |
| OpTmizer™ CTS™ T-Cell Expansion Supplement | Life Technologies Corporation | 1 |
| Dmem (1X) Dulbecco’s Modified Eagle Medium | Life Technologies Corporation | 1 |
| Stemproò MSC SFM Supplement CTS™ | Life Technologies Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K113566 | 2012-06-21 |
| K103302 | 2011-02-18 |
| K100616 | 2010-05-20 |
| DEN000008 | 2001-02-16 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-06-11 | Class II | Vendor change control | Component was not tested by the supplier for adventitious agents | 4724 Kits | 2020-06-04 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | 91 | 2020-05-05 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | 70 | 2020-05-05 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | 10 | 2020-05-05 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | 45 | 2020-05-05 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | 141 | 2020-05-05 |
| 2018-05-10 | Class II | Unknown/Undetermined by firm | It has been determined that the fill port tube seal integrity was compromised during the manufacture of the product lot. This may cause media to leak out of the primary sterile packaging into outer non-sterile dust cover packaging, and subs | Updated as of 6/21/19: 6304 units | 2020-05-05 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.