FDA.reportPublic FDA data

Expression Systems

Primary DI
00850047921628
Brand
Expression Systems
Company
Expression Systems, LLC
Model
ESF AF, 200L Bag in Drum
Catalog number
PBA, 10 L
Published
2025-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00850047921628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047921628008500479216288500479216280850047921628

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Protected from light
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
129743329
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047921611Expression SystemsESF AdvanCD, 200L Bag in Drum2025-03-05
00850047921444Expression SystemsBestBac 2.0 vcath/chiA Linearized Baculovirus DNA2023-01-09
00850047921475Expression SystemsBestBac 2.0 vcath/chiA Baculovirus Cotransfection 2023-01-09
00850047921000Expression SystemsTransfection Medium, 100ml2023-01-05
00850047921017Expression SystemsESF 921, 1L Bottle2023-01-05
00850047921024Expression SystemsESF 921, 8L2023-01-05
00850047921031Expression SystemsESF 921, 10L2023-01-05
00850047921048Expression SystemsESF 921, 20L2023-01-05
00850047921055Expression SystemsESF 921, 50L2023-01-05
00850047921062Expression SystemsESF AF, 1L Bottle2023-01-05
00850047921079Expression SystemsESF AF, 10L2023-01-05
00850047921086Expression SystemsESF AF, 20L2023-01-05
00850047921093Expression SystemsESF AF, 50L2023-01-05
00850047921109Expression SystemsESF AF, 200L2023-01-05
00850047921116Expression SystemsPBA, 100ml2023-01-05
00850047921123Expression SystemsPBA, 1L Bottle2023-01-05
00850047921130Expression SystemsBaculovirus Titering Kit2023-01-05
00850047921147Expression Systemsgp64-PE Antibody, 100ul2023-01-05
00850047921154Expression SystemsESF 921 Delta Series Methionine Deficient,1 L Bot2023-01-05
00850047921161Expression SystemsESF 921 Delta Series All Amino Acid Deficient wit2023-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840075404729TheraPEAK X-VIVO™ 15 without Gentamicin or Phenol RedLonza Walkersville, Inc.KIT2026-05-27
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