FDA.reportPublic FDA data

ZTMV™

Primary DI
G507ZTMV01000
Brand
ZTMV™
Company
Incell Corporation, LLC
Model
ZTMV0100
Catalog number
ZTMV0100
Device description
GMP Transport Media for Viruses with Gentamicin, Clindamycin, Amphotericin B
Published
2023-09-01
Public version status
Update
Distribution status
Not 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
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
G507ZTMV01000PrimaryHIBCC0

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 Volume100Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature2 Degrees Celsius8 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 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
G507ZTMV05000ZTMV™ZTMV0500ZTMV05002023-09-01
G507EZNDHS05000EZ-CPZ-ND+2% Hetastarch (Hs)™EZNDHS0500EZNDHS05002023-09-07
G507ZAPR01000ZAPR™ZAPR0100ZAPR01002023-09-06
G507ZAPR04000ZAPR™ZAPR0400ZAPR04002023-09-06
G507ZSOLF05000ZSol:F™ZSOLF0500ZSOLF05002023-09-06
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
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