FDA.reportPublic FDA data

FACS

Primary DI
00382906641168
Brand
FACS
Company
Becton, Dickinson And Company
Model
664116
Catalog number
664116
Device description
BD FACS™ Sample Prep Assistant III Software v6.0
Published
2020-04-08
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382906641168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906641168003829066411683829066411680382906641168

GMDN Terms#

Term, Definition table
TermDefinition
Laboratory analyser operation system software IVDMainframe or personal computer (PC) based operating system software (or firmware) that is specific to the central processing unit (CPU) incorporated into an analyser or analyser system. This includes the software or firmware based programs and routines supplied by the computer manufacturer that drive a specific computer in the performance of its tasks and assists the operators, applications programmers and programs with various supporting functions. A proprietary name and a "version number" are commonly used to identify different operating system versions.

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
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30382903678717BD Vacutainer® Sodium HeparinN (NH) 75 USP Units Blood Collection Tubes3678713678712016-07-28
50885403530225BD140061-01140061-012026-05-13
50885403530232BD140063-01140063-012026-05-13
50885403530249BD140062-01140062-012026-05-13
50885403530256BD140064-01140064-012026-05-13
50885403530263BD140065-01140065-012026-05-13
50885403530270BD140066-01140066-012026-05-13
50885403530287BD140067-01140067-012026-05-13
50885403530294BD140068-01140068-012026-05-13
30382903678786BD Vacutainer® Sodium HeparinN (NH) 95 USP Units Blood Collection Tubes3678783678782016-07-28
30382903679639BD Vacutainer® PST™ Lithium HeparinN (LH) Blood Collection Tubes3679633679632016-07-28
30382903679608BD Vacutainer® PST™ Gel and Lithium HeparinN 56 Units3679603679602016-07-28
30382903679615BD Vacutainer® PST™ Gel and Lithium HeparinN 65 Units3679613679612016-07-28
30382903679622BD Vacutainer® PST™ Gel and Lithium HeparinN 83 Units3679623679622016-07-28
30382903678748BD Vacutainer® Sodium HeparinN (NH) 158 USP Units Blood Collection Tubes3678743678742016-07-28
00382904422882BD BACTEC™ Myco/F Lytic Culture Vials4422884422882025-02-07
30382903672906BD Vacutainer® Multiple Sample Luer Adapter3672903672902016-12-12
30382903679875BD Vacutainer® SST™3679873679872016-07-28
30382903672876BD Vacutainer® Safety-Lok™ Blood Collection Set3672873672872016-07-28
30382903672920BD Vacutainer® Safety-Lok™ Blood Collection Set3672923672922016-07-28

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
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
00382906472052FACSBecton, Dickinson And CompanyPER2016-06-08