FDA.reportPublic FDA data

NMIC-315

Primary DI
00382904490850
Brand
NMIC-315
Company
BECTON, DICKINSON AND COMPANY
Model
449085
Catalog number
449085
Device description
BD Phoenix™ NMIC-315
Published
2026-01-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
K020322000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020322000BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEMBecton, Dickinson & CO2002-03-27LON

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904490851PrimaryGS10
00382904490850Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290449085130382904490851
00382904490850003829044908503829044908500382904490850

GMDN Terms#

Term, Definition table
TermDefinition
Bacterial 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 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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382903935314Nexiva3935313935312026-07-30
00382903935321Nexiva3935323935322026-07-30
00382903935338Nexiva3935333935332026-07-30
00382903935345Nexiva3935343935342026-07-30
00382903935352Nexiva3935353935352026-07-30
00382903935369Nexiva3935363935362026-07-30
00382903935376Nexiva3935373935372026-07-30
00382903935383Nexiva3935383935382026-07-30
00885403523000FOGARTY SOFTJAWCSOFT6CSOFT62026-07-30
00885403523161FOGARTY HYDRAJAWHYDRA33HYDRA332026-07-30
00885403523253FOGARTY SOFTJAWSOFT33SOFT332026-07-30
00885403523277FOGARTY SOFTJAWSOFT86SOFT862026-07-30
00885403529637Acumen IQAIQCAAIQCA2026-07-29
00885403529668Acumen IQAIQCSAIQCS2026-07-29
00885403529774ClearSight JrCSCJR1CSCJR12026-07-29
00885403529781ClearSightCSCLCSCL2026-07-29
00885403529798ClearSightCSCMCSCM2026-07-29
00885403529811ClearSightCSCSCSCS2026-07-29
00885403529828VitaWaveVWCAVWCA2026-07-29
00885403522393Swan-Ganz834F75834F752026-07-27

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
15099590799717MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799724MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799755MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799762MicroScanBeckman Coulter, Inc.LON2025-12-17
15099590799243MicroScanBeckman Coulter, Inc.LON2025-12-08
15099590799250MicroScanBeckman Coulter, Inc.LON2025-12-08
15099590807146MicroScanBeckman Coulter, Inc.LON2025-12-08
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