BD FACSCount™ 337858

GUDID 00382903378586

BD FACSCount Instrument System

BECTON, DICKINSON AND COMPANY

Flow cytometry analyser IVD, automated
Primary Device ID00382903378586
NIH Device Record Keyeb57c55c-e64d-4b99-9745-a2b853d48f83
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD FACSCount™
Version Model Number337858
Catalog Number337858
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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
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
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

Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Room Temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100382903378586 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-06-08

On-Brand Devices [BD FACSCount™]

00382903446193BD FACSCount System Users Guide and Software
00382903401673BD FACSCount Reagent Kit 50 Tests IVD
00382903401666BD FACSCount Control Kit 25 Tests IVD
00382903390113FACSCount CD4 Users Guide and Software
00382903390106BD FACSCount CD4 Reagent Kit 50 Tests
00382903378586BD FACSCount Instrument System

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