FDA.reportPublic FDA data

BD FACSLyric

Primary DI
00382906628787
Brand
BD FACSLyric
Company
Becton, Dickinson And Company
Model
662878
Catalog number
662878
Device description
BD FACSLyric™ Flow Cytometer
Published
2017-09-27
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
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
00382906628787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382906628787003829066287873829066287870382906628787

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
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
00885403525066TruWave, VAMPPXAVMPPXAVMP2026-07-31
00885403525547TruWave, VAMPPXAVMP3PXAVMP32026-07-31
00885403525608TruWave, VAMPPXVMP172AT3PXVMP172AT32026-07-31
00885403525646TruWave, VAMP PlusPXVP1071PXVP10712026-07-31
00885403529644Acumen IQ CuffAIQCLAIQCL2026-07-31
00885403529651Acumen IQ CuffAIQCMAIQCM2026-07-31
00885403530404Fogarty120404F120404F2026-07-31
00885403530411Fogarty120602F120602F2026-07-31
00885403530428Fogarty120803F120803F2026-07-31
00885403530442Fogarty120804F120804F2026-07-31
00885403530466Fogarty120805F120805F2026-07-31
00885403530565Fogarty12TLW805F3512TLW805F352026-07-31

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
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
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