340542

GUDID 00382903405428

CD3 FITC SK7 250 Tests IVD

BECTON, DICKINSON AND COMPANY

Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Primary Device ID00382903405428
NIH Device Record Key0acbfedb-5b93-47b3-adcd-154290913284
Commercial Distribution StatusIn Commercial Distribution
Version Model Number340542
Catalog Number340542
Company DUNS024230633
Company NameBECTON, DICKINSON AND COMPANY
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

Customer Support Contacts

Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com
Phone+1(877)232-8995
EmailBDBCustomerService@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382903405428 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LIZAssay, t lymphocyte surface marker

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-08-23
Device Publish Date2016-06-27

Devices Manufactured by BECTON, DICKINSON AND COMPANY

10382902212673 - BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and IsoVitaleX™)2026-02-27 BD BBL™ Chocolate II Agar (GC II Agar with Hemoglobin and BD IsoVitaleX™), Ctn. of 100 plates
30382903836483 - Nexiva2026-02-25 BD Nexiva™ Closed IV Catheter System 20GA x 1.75IN (Dual Port w/Cap)
30382903810124 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 24 GA x 0.75 IN
30382903810230 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 22 GA x 1.00 IN
30382903810247 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 22 GA x 1.25 IN
30382903810339 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.00 IN
30382903810346 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.16 IN
30382903810377 - Insyte Autoguard2026-02-23 BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter Blood Control Technology 20 GA x 1.88 IN

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.