FDA.reportPublic FDA data

MEM Amino Acids Solution (50X)

Primary DI
10190302001700
Brand
MEM Amino Acids Solution (50X)
Company
LIFE TECHNOLOGIES CORPORATION
Model
11130051
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
Sterile
true

Product Codes#

Code, Name table
CodeName
KITMEDIA AND COMPONENTS, SYNTHETIC CELL AND TISSUE CULTURE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KITMedia And Components, Synthetic Cell And Tissue CultureHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30190302001704PackageGS120Not in Commercial Distribution
10190302001700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3019030200170430190302001704
1019030200170010190302001700

GMDN Terms#

Term, Definition table
TermDefinition
Cell culture medium IVDA liquid based tissue culture medium containing essential nutrients, sugars, amino acids and growth factors, intended to be used for the in-vitro maintenance, sustenance, and cultivation of human cells from a clinical specimen for diagnostic purposes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118793157
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

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
10190302001236Minimum Essential Medium (MEM) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302003650Dulbeccos Modified Eagle MediumLIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302004459BME, Basal Medium (Eagle) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
10190302004718Minimum Essential Medium (MEM) (1X)LIFE TECHNOLOGIES LIMITEDKIT2023-10-02
00840075400141X-VIVO 10 w/o Gent,PR&w/ RecTrnsfrn 50LLonza Walkersville, Inc.KIT2022-12-08
00840075400202STD ProCHO 5 Powder, 500 LLonza Walkersville, Inc.KIT2022-12-08
00840075400233RoosterBasal(TM)-MSC-CC, 500mlLonza Walkersville, Inc.KIT2022-12-08
00840075400264Insect-XPRESS w/ L-Gln 1 LLonza Walkersville, Inc.KIT2022-12-08
00840075400301TheraPEAK™ SfAAV™ 1L bottleLonza Walkersville, Inc.KIT2022-12-08
00840075400349VEGGIE 10 MEDIUM WITH ADDITIVES, 200LLonza Walkersville, Inc.KIT2022-12-08
00840075400356TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075400363Solution E LifeCell p/n 131P0063, lL botLonza Walkersville, Inc.KIT2022-12-08
00840075400370TheraPEAK™ Lymphocyte Separation MediumLonza Walkersville, Inc.KIT2022-12-08
00840075400493UltraCULTURE, 200L bagLonza Walkersville, Inc.KIT2022-12-08
00840075400653TheraPEAK™ X-VIVO™ 15 w/o Gent or PR, 5LLonza Walkersville, Inc.KIT2022-12-08
00840075400677HAL-MEM WITH LAH #00-0704-00, 200L bagLonza Walkersville, Inc.KIT2022-12-08
00840075400936Solution E LifeCell 131P0077-02, 100L drLonza Walkersville, Inc.KIT2022-12-08
00840075400981RPMI1640 4.5g/L GLUC,NAHCO3,W/O GLUT,50LLonza Walkersville, Inc.KIT2022-12-08
00840075400998TheraPEAK ACK Lysing Buffer (1x), 100mLLonza Walkersville, Inc.KIT2022-12-08
00840075401049RPMI 1640 W/GLUT. & GENTAM., 500 ml botLonza Walkersville, Inc.KIT2022-12-08
00840075401100Dulbecco's (PBS) w/o Ca and Mg, lL botLonza Walkersville, Inc.KIT2022-12-08
00840075401179SOLUTION Z LIFECELL P/N 131P0120, 75LLonza Walkersville, Inc.KIT2022-12-08
008400754012234Cell Insect CD Medium, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075401292STD PowerCHO Advance 100 LLonza Walkersville, Inc.KIT2022-12-08
00840075401414ProCHO 5 serum-free media 1 LLonza Walkersville, Inc.KIT2022-12-08
00840075401476STD PowerCHO Advance 10LLonza Walkersville, Inc.KIT2022-12-08
00840075401483Solution Z LifeCell P/N 131P0115, 1LLonza Walkersville, Inc.KIT2022-12-08
00840075401544STD PowerCHO-2w/oPEG,InsProlpCit2777.8gLonza Walkersville, Inc.KIT2022-12-08
00840075401629ProCHO 4 w/o Phenol Red, 1 LLonza Walkersville, Inc.KIT2022-12-08
00840075401643Veggie 10 Medium with Additives-20L bagLonza Walkersville, Inc.KIT2022-12-08