FDA.report

DMEM (Dulbecco's Modified Eagle Medium)

Primary DI
10190302002134
Brand
DMEM (Dulbecco's Modified Eagle Medium)
Company
LIFE TECHNOLOGIES CORPORATION
Model
11965175
Published
2016-08-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
false

Related Records

Product Codes

CodeName
NDSMEDIA, CULTURE, EX VIVO, TISSUE AND CELL

Product Code Classifications

CodeDeviceSpecialtyClass
NDSMedia, Culture, Ex Vivo, Tissue And CellGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10190302002134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1019030200213410190302002134

GMDN Terms

TermDefinition
Ex vivo cell culture mediumA 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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
118793157
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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