FDA.reportPublic FDA data

ZSol:F™

Primary DI
G507ZSOLF05000
Brand
ZSol:F™
Company
Incell Corporation, LLC
Model
ZSOLF0500
Catalog number
ZSOLF0500
Device description
Bioprocessing Phosphate Buffer without Ca+2 and Mg+2
Published
2023-09-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KIPFormulations, Balanced Salt Solutions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KIPFormulations, Balanced Salt SolutionsHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G507ZSOLF05000PrimaryHIBCC0

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume500Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature10 Degrees Celsius32 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-364-1765info@incell.com

Regulatory Flags#

DUNS number
965420953
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G507M400F01000M4:BaseF™M400F0100M400F01002025-08-11
G507M400F05000M4:BaseF™M400F0500M400F05002025-08-11
G507ZEFR01000ZEFR™ZEFR0100ZEFR01002023-10-02
G507ZTMV01000ZTMV™ZTMV0100ZTMV01002023-09-01
G507ZTMV05000ZTMV™ZTMV0500ZTMV05002023-09-01
G507EZNDHS05000EZ-CPZ-ND+2% Hetastarch (Hs)™EZNDHS0500EZNDHS05002023-09-07
G507ZAPR01000ZAPR™ZAPR0100ZAPR01002023-09-06
G507ZAPR04000ZAPR™ZAPR0400ZAPR04002023-09-06
G507EZCZ01000EZ-CPZ™EZCZ0100EZCZ01002023-09-01
G507EZCZ05000EZ-CPZ™EZCZ0500EZCZ05002023-09-01
G507EZND01000EZ-CPZ-ND™EZND0100EZND01002023-09-01
G507EZND05000EZ-CPZ-ND™EZND0500EZND05002023-09-01
G507M300A01000M3:BaseA™M300A0100M300A01002023-09-01
G507M300A05000M3:BaseA™M300A0500M300A05002023-09-01
G507M300F01000M3:BaseF™M300F0100M300F01002023-09-01
G507M300F05000M3:BaseF™M300F0500M300F05002023-09-01
G507M310A01000M3:10A™M310A0100M310A01002023-09-01
G507M310A05000M3:10A™M310A0500M310A05002023-09-01
G507M3DEC01000M3:DC™M3DEC0100M3DEC01002023-09-01
G507M3DEC05000M3:DC™M3DEC0500M3DEC05002023-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979203760278Chiwell BiotechnologyNingbo Chiwell Biotechnology Co., LtdKIP2026-01-07
05407010128505DPBS 0.0095M(PO4) w/o Ca,Mg-500mL sampleLonza VerviersKIP2025-08-20
05407010127454PBS w/o Ca-Mg 5L JerrycanLonza VerviersKIP2025-06-11
05407010127461PBS w/o Ca-Mg 1L bottleLonza VerviersKIP2025-06-11
05407010127478PBS w/o Ca-Mg Tween 20 0.1% 5L jerrycanLonza VerviersKIP2025-06-11
05407010127485Physiologic Water Tween20 0.05% 5LjerrycLonza VerviersKIP2025-06-11
05407010127492DPBS 1X with 1M NaCl - 10 L BagLonza VerviersKIP2025-06-11
05407010127508DPBS 1X - 20 L Bag Lonza VerviersKIP2025-06-11
05407010127515DPBS 1X with 0.06M NaCl - 20L bagLonza VerviersKIP2025-06-11
05407010127522DPBS 1X with 0.4M NaCl - 20L bagLonza VerviersKIP2025-06-11
05407010127539DPBS 1X with 0.08M NaCl - 10 L bagLonza VerviersKIP2025-06-11
05407010127546IBEX PBS : 1000L BagLonza VerviersKIP2025-06-11
05407010127553IBEX PBS : 1L Bag SAMPLELonza VerviersKIP2025-06-11
05407010127560DPBS IC51 1L bagLonza VerviersKIP2025-06-11
05407010127577DPBS IC51 20LLonza VerviersKIP2025-06-11
05407010127133DPBS 0.0095M(PO4) w/o Ca,Mg,500mlINTERNELonza VerviersKIP2025-05-26
05407010127140DPBS 0.0095M(PO4) w/o Ca, Mg, 1L INTERNELonza VerviersKIP2025-05-26
05407010126938DPBS 0.0095M(PO4) w/o Ca,Mg-250ml sample Lonza VerviersKIP2025-05-14
05407010126174NCTF Powder - 5LLonza VerviersKIP2025-03-20
05407010125726NCTF Powder - 380gLonza VerviersKIP2025-01-08
16974488990713iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
16974488990720iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
06974488990716iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
06974488990723iCleanHuachenyang (Shenzhen) Technology Co., LtdKIP2023-10-24
10190302001069Phosphate-Buffered Saline (PBS) (1X), pH 7.4LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002660Hanks’ Balanced Salt Solution (HBSS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002707Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002714Dulbecco’s Phosphate Buffered Saline (D-PBS) (1X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002752Hanks’ Balanced Salt Solution (HBSS) (10X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02
10190302002776Dulbecco’s Phosphate Buffered Saline (D-PBS) (10X)LIFE TECHNOLOGIES LIMITEDKIP2023-10-02