FDA.reportPublic FDA data

BD PrepStain Slide Processor

Primary DI
00382904904074
Brand
BD PrepStain Slide Processor
Company
BECTON, DICKINSON AND COMPANY
Model
490407
Catalog number
490407
Device description
PrepStain® Slide Processor (Refurb)
Published
2015-07-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MKQProcessor, Cervical Cytology Slide, Automated

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970018001

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970018001BD PREPSTAIN SYSTEMBd Diagnostic Systems1999-06-17MKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00382904904074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00382904904074003829049040743829049040740382904904074

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide maker/stainer IVD, automatedA mains electricity (AC-powered) laboratory instrument intended to be used to prepare, transfer or fix blood, tissue or other clinical specimens onto microscope examination slides, and then stain the slides using one or more biological or cytochemical staining solutions in preparation for subsequent microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth25Inch
Height34Inch
Width40Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius50 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
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
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00382905167041BD Intelliport5167045167042020-09-30
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00382904003739BD Whitacre Spinal4003734003732023-09-02
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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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
15420045513860ThinPrepHologic, Inc.MKQ2024-05-20
15420045514133ThinPrepHologic, Inc.MKQ2024-05-20
15420045514140ThinPrepHologic, Inc.MKQ2024-05-20
15420045514157ThinPrepHologic, Inc.MKQ2024-05-20
25420045514680ThinPrep Pap TestHologic, Inc.MKQ2021-09-29
15420045514683ThinPrep Pap TestHologic, Inc.MKQ2021-09-29
15420045514652ThinPrep® Pap TestHologic, Inc.MKQ2021-09-17
15420045513945ThinPrep 5000 ProcessorHologic, Inc.MKQ2020-09-25
15420045513952ThinPrep 5000 ProcessorHologic, Inc.MKQ2020-09-25
10382904913318BD Syringing PipettesBECTON, DICKINSON AND COMPANYMKQ2018-10-01
10382904914520BD SurePath™ Collection VialBECTON, DICKINSON AND COMPANYMKQ2018-08-23
30382904914524BD SurePath™ Collection VialBECTON, DICKINSON AND COMPANYMKQ2018-08-23
00382904914530BD Totalys™ MultiProcessor Consumables KitBECTON, DICKINSON AND COMPANYMKQ2018-08-22
00382904914547BD PrepStain™ Consumables KitBECTON, DICKINSON AND COMPANYMKQ2018-08-22
00382904914554BD PrepMate™ Consumables KitBECTON, DICKINSON AND COMPANYMKQ2018-08-22
00382904914561BD Totalys™ SlidePrep Consumables KitBECTON, DICKINSON AND COMPANYMKQ2018-08-03
10382904912533BD SurePath™ Collection Vial Kit 500TRIPATH IMAGING, INC.MKQ2017-09-08
10382904905276SurePath Preservative Fluid Collection VialBECTON, DICKINSON AND COMPANYMKQ2017-09-08
30382904912483BD SurePath™ PreCoat SlidesBECTON, DICKINSON AND COMPANYMKQ2017-09-08
30382904913312BD Syringing PipettesBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904911034BD PrepMate™ Automated AccessoryBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904912475BD SurePathTRIPATH IMAGING, INC.MKQ2017-09-08
00382904912574BD PrepMate™ Automated AccessoryBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904912666BD SurePath™ Manual Method KitBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904912673BD PrepStain™ Slide Library KitBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904912888BD PrepMate™ Installation KitBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904912895BD PrepStain™ Install KitBECTON, DICKINSON AND COMPANYMKQ2017-09-08
00382904913069BD Density ReagentTRIPATH IMAGING, INC.MKQ2017-09-08
00382904913113BD PrepStain™ Consumables KitTRIPATH IMAGING, INC.MKQ2017-09-08
00382904913137BD PrepMate™ Consumables KitTRIPATH IMAGING, INC.MKQ2017-09-08