FDA.reportPublic FDA data

BD PhoenixSpec™ Calibrator 0.25 McFarland

Primary DI
00382904413552
Brand
BD PhoenixSpec™ Calibrator 0.25 McFarland
Company
BECTON, DICKINSON AND COMPANY
Model
441355
Catalog number
441355
Device description
BD PhoenixSpec™ Calibrator 0.25 McFarland
Published
2018-05-25
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
JQXNEPHELOMETER, FOR CLINICAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQXNephelometer, For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904413552PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904413552003829044135523829044135520382904413552

GMDN Terms#

Term, Definition table
TermDefinition
Microorganism-density nephelometer IVDA mains electricity (AC-powered) laboratory instrument intended to be used to determine the density of microorganism suspensions by comparing the turbidity of a solution with that of McFarland standards using a photometric detection system.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature20 Degrees Celsius30 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
00382904440640BD Kiestra™ ID AST Calibrator KitBECTON, DICKINSON AND COMPANYJQX2024-08-29
05032384474516SENSITITRE NEPHELOMETERTREK DIAGNOSTIC SYSTEMS LIMITEDJQX2022-12-14
15099590265403IMMAGEBeckman Coulter, Inc.JQX2020-08-24
00382902450153BD BBL™ CrystalSpec™ Calibration TubesBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904409104BD PhoenixSpec™ NephelometerBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904409111BD PhoenixSpec™ Calibrator KitBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904413569BD PhoenixSpec™ Calibrator 0.50 McFarlandBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904419516BD PhoenixSpec™ AP Calibrator KitBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904419530BD PhoenixSpec™ Calibrator 2.0 McFarlandBECTON, DICKINSON AND COMPANYJQX2018-05-25
00382904480103BD Phoenix™ APBECTON, DICKINSON AND COMPANYJQX2018-05-25