FDA.reportPublic FDA data

DMEM (Dulbecco's Modified Eagle Medium)

Primary DI
30190302002343
Brand
DMEM (Dulbecco's Modified Eagle Medium)
Company
LIFE TECHNOLOGIES CORPORATION
Model
12430054
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

Product Codes#

Code, Name table
CodeName
NDSMEDIA, CULTURE, EX VIVO, TISSUE AND CELL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDSMedia, Culture, Ex Vivo, Tissue And CellGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30190302002343PackageGS110Not in Commercial Distribution
10190302002349PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019030200234330190302002343
1019030200234910190302002349

GMDN Terms#

Term, Definition table
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 table
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10190302018449QuantStudio™ 7 Pro Dx Software, V3.0.0A546262022-09-12
10190302018159appliedbiosystems QuantStudioTM 7 Pro Dx SoftwareA52649, V2.0.02022-05-02
10190302017862QuantStudio™ 7 Pro Dx SoftwareA52015, V1.0.52021-12-10
10190302002691Dulbecco's Phosphate Buffered Saline (D-PBS)140401412016-08-04
10190302000635Dulbecco's Phosphate Buffered Saline (D-PBS)141901362016-08-01
10190302002684Hanks' Balanced Salt Solution (HBSS)140250922016-08-04
10190302002721Dulbecco's Phosphate Buffered Saline (D-PBS)140401332016-08-04
10190302002837Hanks' Balanced Salt Solution (HBSS)141701122016-08-04
10190302002844Hanks' Balanced Salt Solution (HBSS)141750952016-08-04
10190302002875Hanks' Balanced Salt Solution (HBSS)141750792016-08-04
10190302003018Dulbecco's Phosphate Buffered Saline (D-PBS)142000752016-08-04
10190302003858Hanks' Balanced Salt Solution (HBSS)240201172016-08-04
10190302000628Dulbecco's Phosphate Buffered Saline (D-PBS)140401172016-08-01
10190302002950Dulbecco's Phosphate Buffered Saline (D-PBS)141901442016-08-01
10190302019439Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution BufferA577402025-02-17
10190302018982TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564402025-02-17
10190302018999TaqPath™ COVID-19, Flu A, Flu B, RSV Select Positive Control9636122025-02-17
10190302019002TaqPath™ COVID-19, Flu A, Flu B, RSV Select Negative Control9636092025-02-17
10190302019019TaqPath™ 1-Step Select Master Mix (No ROX)A56518A561232025-02-17
10190302019026TaqPath™ COVID-19, Flu A, Flu B, RSV Select AssayA564412025-02-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05407010122565STD X-Vivo 15 w/o gentamicin and pr, 1LLonza VerviersNDS2022-09-12
05407010122572X-Vivo10 w/o Gent, PR w/ Rec Transf, 10LLonza VerviersNDS2022-09-12
05407010122589X-VIVO 15 w/o Gentamycin and PR - 3L bagLonza VerviersNDS2022-09-12
05407010122756X-VIVO 15 w/o PR and Gentamicine 10L bagLonza VerviersNDS2022-09-12
05407010122817TheraPEAK™ X-VIVO™ 15 w REC TRANSF 1LLonza VerviersNDS2022-09-12
05407010122824TheraPEAK X-VIVO10(04-743) contains rec transf -1LLonza VerviersNDS2022-09-12
05407010122831X-VIVO 10 w/o Gentamycin w/o PR, 1LLonza VerviersNDS2022-09-12
05407010122848TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1LLonza VerviersNDS2022-09-12
05407010122541X-Vivo 15 w/o gentamicin and pr, 5LLonza VerviersNDS2022-09-06
05407010122558STD X-Vivo 15 w/o gentamicin and pr, 5LLonza VerviersNDS2022-09-06
05407010122626X-Vivo15(04-744)contains rec tran 1L bagLonza VerviersNDS2022-09-06
05407010122633X-Vivo15(04-744) contains rec transf, 1LLonza VerviersNDS2022-09-06
05407010122640X-VIVO10(04-743) contains rec transf -1LLonza VerviersNDS2022-09-06
05407010122657X-VIVO 10 w/o Gentamycin w/o PR 1LLonza VerviersNDS2022-09-06
05407010122664X-VIVO 15 w/o Gentamycin and PR, 1 LLonza VerviersNDS2022-09-06
05407010122947X-Vivo15(04-418) contains rec transf, 1LLonza VerviersNDS2022-09-06
05407010122954TheraPEAK X-VIVO 15 w/o Gentamycin and PR, 1 LLonza VerviersNDS2022-09-06
10190302014274CTS™ OpTmizer™ T-Cell Expansion Basal MediumLIFE TECHNOLOGIES CORPORATIONNDS2018-06-15
30190302014278CTS™ OpTmizer™ T-Cell Expansion Basal MediumLIFE TECHNOLOGIES CORPORATIONNDS2018-06-15
10190302014281CTS™ OpTmizer™ T-Cell Expansion Basal MediumLIFE TECHNOLOGIES CORPORATIONNDS2018-06-15
10190302014298CTS™ OpTmizer™ T-Cell Expansion SupplementLIFE TECHNOLOGIES CORPORATIONNDS2018-06-15
10190302014250CTS™ AIM-V™ MediumLIFE TECHNOLOGIES CORPORATIONNDS2018-04-13
30190302014254CTS™ AIM-V™ MediumLIFE TECHNOLOGIES CORPORATIONNDS2018-04-13
10190302014267CTS™ AIM-V™ MediumLIFE TECHNOLOGIES CORPORATIONNDS2018-04-13
10190302000543DMEM (1X) Dulbecco's Modified Eagle MediumLIFE TECHNOLOGIES CORPORATIONNDS2016-08-01
10190302001229DMEM (Dulbecco's Modified Eagle Medium)LIFE TECHNOLOGIES CORPORATIONNDS2016-08-01
10190302001434DMEM (Dulbecco's Modified Eagle Medium)LIFE TECHNOLOGIES CORPORATIONNDS2016-08-01
10190302001472DMEM (Dulbecco's Modified Eagle Medium)LIFE TECHNOLOGIES CORPORATIONNDS2016-08-01
10190302001496DMEM (Dulbecco's Modified Eagle Medium)LIFE TECHNOLOGIES CORPORATIONNDS2016-08-01
10190302001502DMEM (Dulbecco's Modified Eagle Medium)LIFE TECHNOLOGIES CORPORATIONNDS2016-08-01