BD SurePath™ Collection Vial Kit 25

Primary DI
30382904913244
Brand
BD SurePath™ Collection Vial Kit 25
Company
TRIPATH IMAGING, INC.
Model
491324
Catalog number
491324
Device description
BD SurePath™ Collection Vial Kit 25
Published
2016-06-23
Public version status
Update
Distribution status
Not 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
MKQProcessor, Cervical Cytology Slide, Automated

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P970018000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P970018000BD PREPSTAIN SYSTEMBd Diagnostic Systems1999-06-17MKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30382904913244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3038290491324430382904913244

GMDN Terms#

Term, Definition table
TermDefinition
Papanicolaou smear kitA packaged collection of instruments, equipment, and reagents required to obtain a cytology sample from the cervix and perform a Papanicolaou test (PAP). Commonly known as a Pap smear or Pap test the cells are typically smeared onto a microscope slide or mixed in a liquid fixative for microscopic examination. A Pap test is usually done as part of a woman's regular pelvic examination. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)638-8663Technical_Services@bd.com
800-638-8663technical_services@bd.com

Regulatory Flags#

DUNS number
103318015
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10382904912533BD SurePath™ Collection Vial Kit 5004912534912532017-09-08
10382904905245ROVERS® CERVEX-BRUSH® 4905244905242016-09-24
10382904905269Rovers ® Combo-brush® 4905264905262016-09-24
00382904913083BD Totalys™ SlidePrep Consumables Kit4913084913082016-06-23
00382904913113BD PrepStain™ Consumables Kit4913114913112017-09-08
00382904913137BD PrepMate™ Consumables Kit4913134913132017-09-08
00382904913106BD Totalys™ MultiProcessor Consumables Kit4913104913102016-06-23
30382904913299BD Settling Chambers4913294913292015-05-05
30382904913305BD Settling Chambers4913304913302015-05-05
00382904912475BD SurePath4912474912472017-09-08
00382904913069BD Density Reagent4913064913062017-09-08
00382904913885BD Totalys™ SlidePrep Slide Library Kit4913884913882016-06-23
30382904905119BD SurePath4905114905112015-07-23
30382904905171PrepStain® Syringing Pipettes 4905174905172015-05-05
30382904905201PrepStain® Settling Chambers4905204905202015-05-05
30382904905225BD SurePath4905224905222015-07-23
00382904901042BD PrepStain Slide Processor4901044901042015-07-22
00382904904104BD PrepStain Slide Processor4904104904102015-07-22
00382904905071BD SurePath4905074905072015-07-22
00382904905217BD PrepStain4905214905212015-07-22

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