ZDAN™ ZDAN04

GUDID G507ZDAN040

A ZOICX Additive Sterile Filtered

Incell Corporation, LLC

Cell culture medium IVD
Primary Device IDG507ZDAN040
NIH Device Record Key16dd64a4-f42c-4168-87ce-0ec18b9431fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameZDAN™
Version Model NumberZDAN04
Catalog NumberZDAN04
Company DUNS965420953
Company NameIncell Corporation, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com
Phone800-364-1765
Emailinfo@incell.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius
Handling Environment TemperatureBetween -80 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG507ZDAN040 [Primary]

FDA Product Code

KITMedia And Components, Synthetic Cell And Tissue Culture

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-11
Device Publish Date2023-09-01

Devices Manufactured by Incell Corporation, LLC

G507ZEFR01000 - ZEFR™2023-10-10 Chemically Defined Secretome Collection Media
G507EZNDHS05000 - EZ-CPZ-ND+2% Hetastarch (Hs)™2023-09-15 Donor-organ/tissue/cell preservation solution
G507ZAPR01000 - ZAPR™2023-09-14 Red Blood Cell Lysing Buffer
G507ZAPR04000 - ZAPR™2023-09-14 Red Blood Cell Lysing Buffer
G507ZSOLF05000 - ZSol:F™2023-09-14 Bioprocessing Phosphate Buffer without Ca+2 and Mg+2
G507EZCZ01000 - EZ-CPZ™2023-09-11 High Performance Cryopreservation Media and Storage Solution
G507EZCZ05000 - EZ-CPZ™2023-09-11 High Performance Cryopreservation Media and Storage Solution
G507EZND01000 - EZ-CPZ-ND™2023-09-11 High Performance Cryopreservation Media and Storage Solution without DMSO

Trademark Results [ZDAN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ZDAN
ZDAN
85239093 4034307 Dead/Cancelled
Midland Distribution, Inc.
2011-02-10
ZDAN
ZDAN
78331919 2941783 Live/Registered
MIDLAND DISTRIBUTION, INC.
2003-11-23

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.