Human CD3 TRI-COLOR®/CD4 R-PE/CD8 FITC Conjugate

GUDID 10190302005265

LIFE TECHNOLOGIES CORPORATION

Multiple CD cell marker IVD, reagent Multiple CD cell marker IVD, reagent Multiple CD cell marker IVD, reagent Multiple CD cell marker IVD, reagent
Primary Device ID10190302005265
NIH Device Record Keybd2008ec-1243-4929-9d22-832976d5b316
Commercial Distribution Discontinuation2022-04-27
Commercial Distribution StatusNot in Commercial Distribution
Brand NameHuman CD3 TRI-COLOR®/CD4 R-PE/CD8 FITC Conjugate
Version Model NumberCD348A
Company DUNS080131636
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
GS110190302005265 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, differential cell

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2022-05-23
Device Publish Date2016-08-01

Devices Manufactured by LIFE TECHNOLOGIES CORPORATION

10190302010320 - Human CD138 R-PE Conjugate2023-11-30
10190302010337 - Human CD138 PE-Cy®5.5 Conjugate2023-11-30
10190302011730 - Human CD61 APC Conjugate2023-11-30
10190302000680 - 3500Dx Series Polymer Pouch Caps2023-11-20
10190302000116 - Histostain® Plus Broad Spectrum2023-10-18
10190302000123 - invitrogen2023-10-18
10190302000130 - invitrogen2023-10-18
10190302008242 - Histostain® Plus 3rd Gen IHC Detection Kit (1000 Slides)2023-10-18

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.