BD Simultest™ 340039

GUDID 00382903400393

Simultest CD4 FITC/CD8 PE SK3/SK1 IVD

BECTON, DICKINSON AND COMPANY

Multiple mature lymphocyte cell marker IVD, kit, fluorescent activated cell sorting/flow cytometry (FACS/Flow)
Primary Device ID00382903400393
NIH Device Record Keyecae858b-ca38-49fd-a38b-2d331fd5dd32
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Simultest™
Version Model Number340039
Catalog Number340039
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 Perscriptionfalse
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100382903400393 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2016-06-08

On-Brand Devices [BD Simultest™]

00382903492176Simultest IMK Plus Kit 50 Tests IVD
00382903492114Simultest CD3 FITC/CD19 PE SK7/4G7 IVD
00382903401826Simultest IMK-Lymphocyte Kit IVD
00382903400485Simultest CD3 FITC/Anti HLA-DR PE IVD
00382903400447Simultest CD3 FITC/CD8 PE SK7/SK1 IVD
00382903400430Simultest CD3 FITC/CD4 PE SK7/SK31 IVD
00382903400423SIMULTEST CD3/CD16+CD56 IVD
00382903400416Simultest IgG1/IgG2a Isotype Control IVD
00382903400409Simultest Leucogate CD45/CD14 IVD
00382903400393Simultest CD4 FITC/CD8 PE SK3/SK1 IVD

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