FDA.reportPublic FDA data

FACSuite

Primary DI
00382906642363
Brand
FACSuite
Company
Becton, Dickinson And Company
Model
664236
Catalog number
664236
Device description
BD FACSuite™ Clinical, BD Multitest™ 4-Color Assays
Published
2022-12-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K170974000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170974000BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNKBecton, Dickinson and Company2017-07-03OYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382906642363PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906642363003829066423633829066423630382906642363

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
30382902263068BD BBL™ Prompt™ Inoculation System2263062263062016-04-29
30382904203147BD SurePrep™ Capillary Tubes- PLAIN4203144203142018-05-25
30382904203154BD SurePrep™ Capillary Tubes- PLAIN4203154203152018-05-25
30382904203161BD SurePrep™ Capillary Tubes- HEPARINIZED4203164203162018-05-25
30382904203178BD SurePrep™ Capillary Tubes- HEPARINIZED4203174203172018-05-25
30382904203185BD SurePrep™ Capillary Tubes- PRECALIBRATED4203184203182018-05-25
00885403530534Fogarty12TLW404F12TLW404F2026-08-14
00885403530541Fogarty12TLW803F12TLW803F2026-08-14
00885403530558Fogarty12TLW804F12TLW804F2026-08-14
00885403530572Fogarty12TLW806F12TLW806F2026-08-14
00885403530589FOGARTY12TLW807F12TLW807F2026-08-14
00382904411244BD ProbeTec™ (GC) Qx Amplified DNA Assay4411244411242016-07-07
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

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
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
00382906624147N/ABecton, Dickinson And CompanyOYE2017-08-30