DEVICE: OpTmizer™ CTS™ T-Cell Expansion Basal Medium (10190302005142)
Device Identifier (DI) Information
OpTmizer™ CTS™ T-Cell Expansion Basal Medium
A1022103
Not in Commercial Distribution
LIFE TECHNOLOGIES CORPORATION
A1022103
Not in Commercial Distribution
LIFE TECHNOLOGIES CORPORATION
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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62068 | Ex vivo cell culture medium |
A solution used for the ex-vivo culture of human-derived or non-human cells [e.g., T-lymphocytes, mesenchymal stem cells (MSCs), embryonic stem cells, induced pluripotent stem cells (iPSC)] or immortalised cell lines (e.g., HaCat, HeLa, HEK-293, cos-7, PC-12) intended for cell therapy applications. The solution contains a combination of nutrients, which may include amino acids, vitamins and organic salts that are vital for the growth and maintenance of the cell type/line. It is not intended for in vitro fertilization (IVF) or in vitro diagnostic applications.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NDS | MEDIA, CULTURE, EX VIVO, TISSUE AND CELL |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K113566 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
23b889ab-e8ce-4685-a32d-c74e3e5ab62d
August 13, 2020
6
August 01, 2016
August 13, 2020
6
August 01, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined