FDA.reportPublic FDA data

BD Phoenix™ YEAST ID

Primary DI
00382904483166
Brand
BD Phoenix™ YEAST ID
Company
BECTON, DICKINSON AND COMPANY
Model
448316
Catalog number
448316
Device description
BD Phoenix™ YEAST ID
Published
2018-05-25
Public version status
Update
Distribution status
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
JXBKIT, IDENTIFICATION, YEAST

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXBKit, Identification, YeastMicrobiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904483167PackageGS125In Commercial Distribution
00382904483166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3038290448316730382904483167
00382904483166003829044831663829044831660382904483166

GMDN Terms#

Term, Definition table
TermDefinition
Yeast 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 a Yeast 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
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
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
00848838058455Remel™ RapID™ ERIC™ (ELECTRONIC RAPID IDENTIFICATION COMPENDIUM)REMEL, INC.JXB2024-11-13
00848838022432BACTICARDREMEL, INC.JXB2022-12-23
15099590658106MicroScanBeckman Coulter, Inc.JXB2022-12-05
15099590655716MicroScanBeckman Coulter, Inc.JXB2022-11-15
15099590655792MicroScanBeckman Coulter, Inc.JXB2022-11-15
15099590655839MicroScanBeckman Coulter, Inc.JXB2022-11-15
00848838058233Remel REMEL, INC.JXB2021-11-12
30848838058234Remel REMEL, INC.JXB2021-11-12
03848838058230Remel REMEL, INC.JXB2021-11-12
03573026529697VITEK® 2 YSTBIOMERIEUX , INC.JXB2020-06-02
03573026131937VITEK® 2 YSTBIOMERIEUX , INC.JXB2020-06-02
03573026048082API® 20 C AUXBIOMERIEUX SAJXB2020-04-10
03573026066383ID 32 CBIOMERIEUX SAJXB2020-04-10
30382904483167BD Phoenix™ Yeast IDBECTON, DICKINSON AND COMPANYJXB2018-05-25