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
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

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