FDA.reportPublic FDA data

FACSDiva

Primary DI
00382906654212
Brand
FACSDiva
Company
Becton, Dickinson And Company
Model
665421
Catalog number
665421
Device description
BD FACSDiva™ Software v 9.2
Published
2022-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GKZCounter, differential cell
OYEFlow cytometric reagents and accessories.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKZCounter, Differential CellHematology2
OYEFlow Cytometric Reagents And Accessories.Hematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040725000
K141468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040725000BD FACSCANTO SYSTEMBecton Dickinson Immunocytometry Systems2004-09-10GKZ
K141468000BD FACSCanto II flow cytometer (4-2-2 and 5-3 configurations), BD FACSCanto flow cytometer (4-3-3 configuration)Bd Biosciences2015-02-27OYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382906654212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906654212003829066542123829066542120382906654212

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory instrument/analyser application software IVDAn in vitro diagnostic software program intended to be used with an instrument/analyser (e.g., microscope slide digital imaging scanner, immunoassay analyser, real-time PCR machine), or a data management device connected to the instrument/analyser, to: 1) facilitate user-controlled device function [e.g., incubation control]; 2) assist data processing, display, or communication [e.g., image conversion]; and/or 3) produce raw-data-derived qualitative result calculations based on specified criteria [positive or negative assay result]. This software does not use demographic or clinical data to produce a patient score (i.e., it is not interpretive).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Room Temperature

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(877)232-8995BDBCustomerService@bd.com

Regulatory Flags#

DUNS number
119218200
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382902780519BD Macro-Vue™ Card Test Rotator2780512780512016-05-19
00885403522324Swan-Ganz151F7151F72026-07-31
00885403523581VAMP48VMP10648VMP1062026-07-31
00885403523598VAMP48VMP12048VMP1202026-07-31
00885403523734VAMP48VMP18448VMP1842026-07-31
00885403524281TruWave, VAMP PlusPXVP1087PXVP10872026-07-31
00885403524694TruWave, VAMP PlusPXVP0550PXVP05502026-07-31
00885403524922TruWavePX266CPX266C2026-07-31
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590807696UniCel DxH 900 COULTER Cellular Analysis System (Rebuilt by Beckman Coulter)Beckman Coulter, Inc.GKZ2026-05-19
00860008385888WBC Test StripAthelas, Inc.GKZ2026-04-28
00860008385871Athelas HomeAthelas, Inc.GKZ2026-04-27
00630414289694Atellica HEMA 580 Analyzer (SMS ready)Siemens Healthcare Diagnostics Inc.GKZ2026-02-06
03610230009932ABX Micros 60HORIBA ABX SASGKZ2026-01-23
00380740213565AlinityABBOTT LABORATORIESGKZ2025-12-25
15099590754013DxFLEXBeckman Coulter, Inc.OYE2025-09-02
00850063751117CitoCBC AnalyzerCYTOCHIP INCGKZ2025-07-01
00850063751216CitoCBC CartridgeCYTOCHIP INCGKZ2025-07-01
06944904002422BC-3200 Hematology AnalyzerShenzhen Mindray Bio-Medical Electronics Co., Ltd.GKZ2025-01-17
04987562508440XQ-520 XQ-Series Automated Hematology AnalyzerSYSMEX CORPORATIONGKZ2025-01-14
03610230009444Yumizen H2500HORIBA ABX SASGKZ2024-11-29
03610230009451Yumizen H2500HORIBA ABX SASGKZ2024-11-29
15099590762889Stem-Kit ReagentsBeckman Coulter, Inc.GKZ2024-10-25
15099590762896StemTrol Control CellsBeckman Coulter, Inc.GKZ2024-10-25
07290016991086HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2024-09-02
04987562503131XQ-320 XQ-Series Automated Hematology AnalyzerSYSMEX CORPORATIONGKZ2024-05-24
00382906657329BD FACSuiteBecton, Dickinson And CompanyOYE2024-01-09
00380740138851AlinityABBOTT LABORATORIESGKZ2023-11-16
00382906643438BD Trucount™Becton, Dickinson And CompanyGKZ2023-08-07
00382906642363FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906642370FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906642356FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906635181FACSLyricBecton, Dickinson And CompanyOYE2022-10-12
00382906631282BD FACSDuetBecton, Dickinson And CompanyOYE2022-08-23
20860008385868Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385840Athelas HomeAthelas, Inc.GKZ2022-07-29
00860008385864Athelas HomeAthelas, Inc.GKZ2022-07-29
07290016991079HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2022-07-19
17290016991076HemoScreenPIXCELL MEDICAL TECHNOLOGIES LTDGKZ2022-07-19