FDA.reportPublic FDA data

BD Phoenix™ SMIC-101

Primary DI
30382904488032
Brand
BD Phoenix™ SMIC-101
Company
BECTON, DICKINSON AND COMPANY
Model
448803
Catalog number
448803
Device description
BD Phoenix™ SMIC-101
Published
2016-05-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LONSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short IncubationMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032675000
K050745000
K050747000
K050780000
K050865000
K050881000
K050946000
K050982000
K051109000
K051138000
K051204000
K051266000
K051272000
K051692000
K062206000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032675000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/MLBecton, Dickinson & CO2004-03-01LON
K050745000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/MLBecton, Dickinson & CO2005-04-29LON
K050747000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/MLBecton, Dickinson & CO2005-04-29LON
K050780000BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/MLBecton, Dickinson & CO2005-05-12LON
K050865000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/MLBecton, Dickinson & CO2005-05-20LON
K050881000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/MLBecton, Dickinson & CO2005-05-12LON
K050946000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/MLBecton, Dickinson & CO2005-05-27LON
K050982000BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML)Becton, Dickinson & CO2005-05-24LON
K051109000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/MLBecton, Dickinson & CO2005-06-15LON
K051138000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/MLBecton, Dickinson & CO2005-06-03LON
K051204000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/MLBecton, Dickinson & CO2005-06-24LON
K051266000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/MLBecton, Dickinson & CO2005-07-05LON
K051272000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/MLBecton, Dickinson & CO2005-07-11LON
K051692000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/MLBecton, Dickinson & CO2005-07-14LON
K062206000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/MLBecton, Dickinson & CO2006-09-08LON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904488032PrimaryGS10
00382904488031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290448803230382904488032
00382904488031003829044880313829044880310382904488031

GMDN Terms#

Term, Definition table
TermDefinition
Streptococcus species culture isolate identification/antimicrobial susceptibility profile IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used to determine the identification and antimicrobial susceptibility profile of Streptococcus bacteria species isolated from a clinical specimen by culture.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904453497BD BACTEC™ FXI Culture System Workflow Module4453494453492026-06-02
00382904453503BD BACTEC™ FXI Culture System Analyzer Module4453504453502026-06-02
30382903686545BD Vacutainer® Safety-Lok™ Blood Collection Set Pre-Attached Holder3686543686542024-03-25
00382904003739BD Whitacre Spinal4003734003732023-09-02
00382904003821BD Whitacre Spinal4003824003822023-09-02
30382903666042BD MiniDraw™ SST™ Capillary Blood Collection Tube3666043666042024-06-06
30382903666134BD MiniDraw™ Finger Sleeve, Small3666133666132024-06-06
30382903666141BD MiniDraw™ Finger Sleeve, Medium3666143666142024-06-06
30382903666158BD MiniDraw™ Finger Sleeve, Large3666153666152024-06-06
30382903666165BD MiniDraw™ Finger Sleeve, Extra-Large3666163666162024-06-06
30382903666172BD MiniDraw™ Finger Sizing Tool3666173666172024-06-06
00382904003715BD Whitacre Spinal4003714003712023-09-02
00382904003722BD Whitacre Spinal4003724003722023-09-02
00885403522270Swan-Ganz131F7P2026-05-30
00885403522348SWAN-GANZ CCOMBO V777F82026-05-30
00885403522386Swan-Ganz831F75P2026-05-30
00885403523819VAMPVMP400VMP4002026-05-30
00885403524618TruWave, VAMP PlusPXVP2284AT3PXVP2284AT32026-05-30
00885403524717TruWave, VAMP PlusPXVP0566PXVP05662026-05-30
00885403524779TruWave, VAMP PlusPXVP2272PXVP22722026-05-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07350136800344ASTar BC G- Kit softwareQ-Linea ABLON2026-05-12
30382904490851NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
00382904490850NMIC-315BECTON, DICKINSON AND COMPANYLON2026-01-29
15099590799717MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799724MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799755MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799762MicroScanBeckman Coulter, Inc.LON2025-12-17
03573026647780VITEK® 2 AST-N816BIOMERIEUX , INC.LON2025-11-21
00860012092109LifeScale ASTAffinity Biosensors, LLCLON2025-10-14
00860012092116LSGNAffinity Biosensors, LLCLON2025-10-14
00860012092123LifeScale SensorAffinity Biosensors, LLCLON2025-10-14
03573026615499VITEK® COMPACT PROBIOMERIEUX , INC.LON2025-05-15
03573026618285VITEKBIOMERIEUX , INC.LON2025-05-15
30382904490820NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
30382904490837NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
00382904449575BDXpert™ SystemBECTON, DICKINSON AND COMPANYLON2025-03-20
00382904490829NMIC-312BECTON, DICKINSON AND COMPANYLON2025-03-20
00382904490836NMIC/ID-313BECTON, DICKINSON AND COMPANYLON2025-03-20
00850031114029Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114142Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20
00195893563760Selux AST SystemSelux Diagnostics, Inc.LON2024-12-20
00850031114005Bulk Analyzer Reagent PackSelux Diagnostics, Inc.LON2024-12-20
10850031114026Selux AST Gram Negative PanelSelux Diagnostics, Inc.LON2024-12-20
00850031114036AST InoculatorSelux Diagnostics, Inc.LON2024-12-20
00850031114043AST AnalyzerSelux Diagnostics, Inc.LON2024-12-20
00850031114067PBC Separator with Selux AST SystemSelux Diagnostics, Inc.LON2024-12-20
10850031114149Selux Seaparator Reagent KitSelux Diagnostics, Inc.LON2024-12-20
00850031114135Selux AST Gram Positive PanelsSelux Diagnostics, Inc.LON2024-12-17
03573026641320VITEK® 2 AST-N815BIOMERIEUX , INC.LON2024-11-13
03573026641337VITEK® 2 AST-N815BIOMERIEUX , INC.LON2024-11-13