CTS™ OpTmizer™ T-Cell Expansion Basal Medium

GUDID 10190302014281

LIFE TECHNOLOGIES CORPORATION

Ex vivo cell culture medium
Primary Device ID10190302014281
NIH Device Record Key46c48868-d183-4f23-bdc9-f04c20f5e7d4
Commercial Distribution StatusIn Commercial Distribution
Brand NameCTS™ OpTmizer™ T-Cell Expansion Basal Medium
Version Model NumberA3704003
Company DUNS118793157
Company NameLIFE TECHNOLOGIES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS110190302014281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NDSMEDIA, CULTURE, EX VIVO, TISSUE AND CELL

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-11-18
Device Publish Date2018-06-15

On-Brand Devices [CTS™ OpTmizer™ T-Cell Expansion Basal Medium]

10190302014281A3704003
30190302014278A3704001

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