FDA.reportPublic FDA data

FACSCanto

Primary DI
00382906573384
Brand
FACSCanto
Company
Becton, Dickinson And Company
Model
657338
Catalog number
657338
Device description
BD FACSCanto™ Flow Cytometer
Published
2016-06-08
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
OYEFlow cytometric reagents and accessories.

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141468000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
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
00382906573384PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906573384003829065733843829065733840382906573384

GMDN Terms#

Term, Definition table
TermDefinition
Flow cytometry analyser IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to count, examine and/or sort cells or microscopic particles in a clinical specimen (e.g., blood, urine). Detection of individual components is performed using an optical or electrical detection system based on physical or chemical characteristics, or by detecting immunological markers introduced to the sample during the preanalytical phase and bound via antigen-antibody reactions. The device operates with minimal technician involvement and complete automation of all procedural steps.

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
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30
00885403522386Swan-Ganz831F75P2026-05-30
00885403523819VAMPVMP400VMP4002026-05-30
00885403524618TruWave, VAMP PlusPXVP2284AT3PXVP2284AT32026-05-30
00885403524717TruWave, VAMP PlusPXVP0566PXVP05662026-05-30
00885403524779TruWave, VAMP PlusPXVP2272PXVP22722026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590754013DxFLEXBeckman Coulter, Inc.OYE2025-09-02
00382906657329BD FACSuiteBecton, Dickinson And CompanyOYE2024-01-09
00382906642363FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906642370FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906642356FACSuiteBecton, Dickinson And CompanyOYE2022-12-13
00382906635181FACSLyricBecton, Dickinson And CompanyOYE2022-10-12
00382906654212FACSDivaBecton, Dickinson And CompanyOYE2022-10-12
00382906631282BD FACSDuetBecton, Dickinson And CompanyOYE2022-08-23
00382906650061BD FACSuiteBecton, Dickinson And CompanyOYE2022-07-15
00382906642868FACSDivaBECTON, DICKINSON AND COMPANYOYE2020-05-05
00382906643452BD FACSDivaBecton, Dickinson And CompanyOYE2020-05-05
00382906641106FACSCantoBecton, Dickinson And CompanyOYE2020-04-08
00382906641120FACSCantoBecton, Dickinson And CompanyOYE2020-04-08
00382906641175BD FACSDivaBecton, Dickinson And CompanyOYE2020-04-08
00382906641182BD FACSDivaBecton, Dickinson And CompanyOYE2020-04-08
00382906641243FACSCantoBecton, Dickinson And CompanyOYE2020-04-08
00382906641267FACSCantoBecton, Dickinson And CompanyOYE2020-04-08
00382906629654BD MultitestBecton, Dickinson And CompanyOYE2019-01-14
00382906630032BD FACSuiteBecton, Dickinson And CompanyOYE2018-01-10
00382906630056BD FACSuiteBecton, Dickinson And CompanyOYE2018-01-10
00382906630070BD FACSuiteBecton, Dickinson And CompanyOYE2018-01-10
00382906629678BD MultitestBecton, Dickinson And CompanyOYE2017-12-12
00382906628794FACSBecton, Dickinson And CompanyOYE2017-10-24
00382906628756BD FACSLyricBecton, Dickinson And CompanyOYE2017-09-27
00382906628763BD FACSLyricBecton, Dickinson And CompanyOYE2017-09-27
00382906628770BD FACSLyricBecton, Dickinson And CompanyOYE2017-09-27
00382906628787BD FACSLyricBecton, Dickinson And CompanyOYE2017-09-27
00382906629616N/ABecton, Dickinson And CompanyOYE2017-09-21
00382906623867FACSViaBECTON, DICKINSON AND COMPANYOYE2017-08-31
00382906624130N/ABecton, Dickinson And CompanyOYE2017-08-30