FDA.reportPublic FDA data

BD FocalPoint Slide Profiler

Primary DI
00382904914646
Brand
BD FocalPoint Slide Profiler
Company
BECTON, DICKINSON AND COMPANY
Model
491464
Catalog number
491464
Device description
BD FocalPoint Slide Profiler (RoHS, Universal Voltage)
Published
2019-12-03
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
MNMREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNMReader, Cervical Cytology Slide, AutomatedUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950009022

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950009022AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEMBd Diagnostics1995-09-29MNM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904914646PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904914646003829049146463829049146460382904914646

GMDN Terms#

Term, Definition table
TermDefinition
Cell morphology analyser IVD, manualA mains electricity (AC-powered) manual laboratory instrument intended to be used for the qualitative microscopic examination of blood or other clinical specimens in order to view, count, record and evaluate the morphological characteristics of cells and other biological components. The device typically includes a microscope, camera, monitor and software package and operates with technician involvement in most 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(800)638-8663Technical_services@bd.com

Regulatory Flags#

DUNS number
122561087
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403523512HemoSphere AltaHEMA70CC2HEMA70CC22026-09-18
00885403523536HemoSphere AltaHEMAPSC200HEMAPSC2002026-09-18
00885403533122ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKBB64EKBB2026-09-18
00885403533146TruWave Reusable Cable64EKGE164EKGE12026-09-18
00885403533153ECG Slave Cable for Spaclab PCI and PC2 with Pigtail64EKGE264EKGE22026-09-18
00885403533160TruWave Reusable Cable64EKH64EKH2026-09-18
00885403533610TruWave Reusable Cable70ANHS70ANHS2026-09-18
00885403533634Pressure Slave Cable70ANS70ANS2026-09-18
00885403533641Cable COO Catheter Interface70CC270CC22026-09-18
00885403533665TruWave Reusable CablePX15S162PX15S1622026-09-18
00885403533764Smart Pressure ControllerPC1QPC1Q2026-09-18
00885403533771Smart Pressure Controller Accessory KitPC1QAKPC1QAK2026-09-18
00885403543282TruWave Reusable CablePX12S162PX12S1622026-09-18
00885403543299TruWavePX17S162PX17S1622026-09-18
00885403543305TruWavePX21S162PX21S1622026-09-18
00885403543312TruWavePX6D162PX6D1622026-09-18
00885403543428TruWavePX6T162PX6T1622026-09-18
00885403543435TruWavePX2D162PX2D1622026-09-18
00885403543459TruWavePX11T162PX11T1622026-09-18
00885403543466TruWavePX7D162PX7D1622026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00382904914905BD™ FocalPoint™ Slide Profiler RefurbishedBECTON, DICKINSON AND COMPANYMNM2023-09-08
15420045515062ThinPrep Imaging SystemHologic, Inc.MNM2022-08-24
15420045513716Thinprep Imaging SystemHologic, Inc.MNM2020-06-24
15420045512511ThinPrep Imaging SystemHologic, Inc.MNM2019-12-03
15420045512535ThinPrep Imaging SystemHologic, Inc.MNM2019-12-03
00382904910907BD FocalPoint™ Slide Profiler RefurbishedBECTON, DICKINSON AND COMPANYMNM2019-06-27
15420045508156ThinPrep Imaging SystemHologic, Inc.MNM2018-10-13
15420045508040ThinPrep Imaging SystemHologic, Inc.MNM2018-05-23
15420045508163Thinprep Imaging SystemHologic, Inc.MNM2017-10-13
00382904901899BD FocalPoint™ GS Review StationBECTON, DICKINSON AND COMPANYMNM2017-09-08
15420045507258ThinPrep Imaging SystemHologic, Inc.MNM2017-02-23
15420045507265ThinPrep Imaging SystemHologic, Inc.MNM2017-02-23
00382904910853BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
00382904910860BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
00382904910877BD FocalPointBECTON, DICKINSON AND COMPANYMNM2015-07-22
15420045504035ThinPrep Imaging SystemHologic, Inc.MNM2014-09-22
15420045504103ThinPrep Imaging SystemHologic, Inc.MNM2014-09-22
15420045504042ThinPrep Imaging SystemHologic, Inc.MNM2014-09-08
15420045504080ThinPrep Imaging SystemHologic, Inc.MNM2014-09-08
15420045504097ThinPrep Imaging SystemHologic, Inc.MNM2014-09-08
15420045500891ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500907ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500914ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500921ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500938ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500945ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500976ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500983ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045500990ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02
15420045501003ThinPrep Imaging SystemHologic, Inc.MNM2014-09-02