FACSDiva 665421

GUDID 00382906654212

Software Kit FACSDiva v9.2 IVD

BECTON, DICKINSON AND COMPANY

Laboratory instrument/analyser application software IVD
Primary Device ID00382906654212
NIH Device Record Key797441bb-1c14-4394-9c8a-4f24bd27d514
Commercial Distribution StatusIn Commercial Distribution
Brand NameFACSDiva
Version Model Number665421
Catalog Number665421
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 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
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
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
GS100382906654212 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKZCounter, differential cell
OYEFlow cytometric reagents and accessories.

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-20
Device Publish Date2022-10-12

Devices Manufactured by BECTON, DICKINSON AND COMPANY

00382902451228 - BD BACTEC™ MGIT™ Mycobacteria Growth Indicator Tubes2026-01-15 BD BBL™ MGIT™ Mycobacteria Growth Indicator Tubes, 7 mL, carton of 100 tubes
00382903649327 - BD Vacutainer Urine Complete Cup Kit2026-01-13 KIT URINCOL 13x75C&S 16x100UAP 13x100UA
00382904448721 - BD Enteric Bacterial Panel plus for BD COR™ System2025-12-17 BD Enteric Bacterial Panel plus for BD COR™ System
00382904448738 - BD Enteric Bacterial Panel for BD COR™ System2025-12-17 BD Enteric Bacterial Panel for BD COR™ System
00382904452797 - Enteric Bacterial Panel Diluent for BD COR™ System2025-12-17 Enteric Bacterial Panel Diluent for BD COR™ System
50382903835893 - BD Nexiva™ Diffusics™ Closed IV Catheter System2025-09-17 NEXIVA DIFFUSICS w/MaxZero 18G X 1.75 IN
30382903835967 - BD Nexiva™ Diffusics™ Closed IV Catheter System2025-09-17 NEXIVA DIFFUSICS w/MaxZero 22G X 1.00 IN
30382902560921 - BD Veritor System for Rapid Detection of SARS-CoV-22025-08-29 Veritor SARS-CoV2 assay Gen 2

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