FDA.reportPublic FDA data

FACS

Primary DI
00382906472052
Brand
FACS
Company
Becton, Dickinson And Company
Model
647205
Catalog number
647205
Device description
BD FACS™ Sample Prep Assistant III
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
PERAutomated pipetting, diluting and specimen processing workstations for flow cytometric analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PERAutomated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric AnalysisClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131301000BD FACS SAMPLE PREP ASSISTANT IIIBecton, Dickinson & CO2013-08-02PER

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382906472052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906472052003829064720523829064720520382906472052

GMDN Terms#

Term, Definition table
TermDefinition
Specimen processing instrument IVD, automatedA mains electricity (AC-powered) instrument or platform intended to be used for the automated pre-analytical preparation of a clinical specimen (excluding specimens for microbial culture), which may include the sampling, diluting, and/or aliquoting of clinical specimens and/or any post-analytical processing required, including labelling, storage and/or location data. The device operates with minimal technician involvement and 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
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24
00382906718358Not Applicable6718356718352026-09-24
00382906718365Horizon6718366718362026-09-24
00382906718372Horizon6718376718372026-09-24
00382906718389Horizon6718386718382026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15099590750312CellmekBeckman Coulter, Inc.PER2025-09-02
00382906663405BD FACSDuetBecton, Dickinson And CompanyPER2023-06-12
04987562501908Sample Preparation System PS-10SYSMEX CORPORATIONPER2022-11-30
00382906631282BD FACSDuetBecton, Dickinson And CompanyPER2022-08-23
00382906641144FACSCantoBecton, Dickinson And CompanyPER2020-04-08
00382906641168FACSBecton, Dickinson And CompanyPER2020-04-08
00382906641199FACSCantoBecton, Dickinson And CompanyPER2020-04-08
00382906641229FACSCantoBecton, Dickinson And CompanyPER2020-04-08
00382906577658FACSBecton, Dickinson And CompanyPER2019-02-13
15099590563547TQ-Prep WorkstationBeckman Coulter, Inc.PER2016-09-23
15099590638191PrepPlus 2Beckman Coulter, Inc.PER2016-09-23
00382906466006BD FACSCanto™BECTON, DICKINSON AND COMPANYPER2016-06-08
00382906466020BD FACSCanto™BECTON, DICKINSON AND COMPANYPER2016-06-08