FDA.reportPublic FDA data

Papanicolaou smear kit

Definition
A 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.
GUDID devices
82
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00187207000085Andwin ScientificAndwin Scientific2310572017-08-02
00187207000092Andwin ScientificAndwin Scientific2301102017-08-02
00187207000108Andwin ScientificAndwin Scientific2301002017-08-02
00187207000122Andwin ScientificAndwin Scientific2301802017-08-02
00187207000139Andwin ScientificAndwin Scientific2300802017-08-02
00187207000146Andwin ScientificAndwin Scientific2300752017-08-02
00187207000153Andwin ScientificAndwin Scientific2301602017-08-02
00187207000160Andwin ScientificAndwin Scientific2301522017-08-02
00187207000177Andwin ScientificAndwin Scientific2300402017-08-02
00187207000184Andwin ScientificAndwin Scientific2310482017-08-02
00187207000191Andwin ScientificAndwin Scientific2400802017-08-02
00187207000207Andwin ScientificAndwin Scientific2100702017-08-02
10195594077877CARDINAL HEALTHCardinal Health 200, LLCSNE33CPHRA2021-06-07
10810010890471Aero-MedAERO-MED, LLCBRL1652019-01-16
10810010890501Aero-MedAERO-MED, LLCBRL2052019-01-16
50810010890479Aero-MedAERO-MED, LLCBRL1652019-01-16
50810010890509Aero-MedAERO-MED, LLCBRL2052019-01-16
50195594077875CARDINAL HEALTHCardinal Health 200, LLCSNE33CPHRA2021-06-07
07898027905902KOLPLASTKolplast C IStandard2019-09-13
20888937003165Pap PerfectCoopersurgical, Inc.110802016-09-21
60888937021402BD Surepath Sample Collection KitCoopersurgical, Inc.4905252018-09-21
30382904905119BD SurePathTRIPATH IMAGING, INC.4905112015-07-23
30382904905171PrepStain® Syringing Pipettes TRIPATH IMAGING, INC.4905172015-05-05
30382904905201PrepStain® Settling ChambersTRIPATH IMAGING, INC.4905202015-05-05
30382904905225BD SurePathTRIPATH IMAGING, INC.4905222015-07-23
30382904912483BD SurePath™ PreCoat SlidesBECTON, DICKINSON AND COMPANY4912482017-09-08
30382904913244BD SurePath™ Collection Vial Kit 25TRIPATH IMAGING, INC.4913242016-06-23
30382904913299BD Settling ChambersTRIPATH IMAGING, INC.4913292015-05-05
30382904913305BD Settling ChambersTRIPATH IMAGING, INC.4913302015-05-05
30382904913312BD Syringing PipettesBECTON, DICKINSON AND COMPANY4913312017-09-08
20888937009891Medscand Pap-Perfect Supply TrayCoopersurgical, Inc.60115-20/252016-09-21
20888937009907Medscand Pap-Perfect Supply TrayCoopersurgical, Inc.60115-10/502016-09-21
20888937009914Medscand Pap-Perfect Supply TrayCoopersurgical, Inc.60115-20/502016-09-21
20888937009921Medscand Pap-Perfect Supply TrayCoopersurgical, Inc.10115-10/502016-09-21
20888937009938Medscand Pap-Perfect Supply TrayCoopersurgical, Inc.10115-20/502016-09-21
20888937009945Medscand Pap-Perfect Supply Tray Coopersurgical, Inc.100652016-09-21
20888937010958Medscand® Sample Collection KitCoopersurgical, Inc.025002017-10-10
60888937009950Medscand Pap-Perfect Supply Tray Coopersurgical, Inc.600652016-09-21
00187207000078Andwin ScientificAndwin Scientific2301702017-08-02
10187207000204Andwin ScientificAndwin Scientific2100702017-08-02
20187207000089Andwin ScientificAndwin Scientific2310572017-08-02
20187207000096Andwin ScientificAndwin Scientific2301102017-08-02
20187207000102Andwin ScientificAndwin Scientific2301002017-08-02
20187207000126Andwin ScientificAndwin Scientific2301802017-08-02
20187207000133Andwin ScientificAndwin Scientific2300802017-08-02
20187207000140Andwin ScientificAndwin Scientific2300752017-08-02
20187207000157Andwin ScientificAndwin Scientific2301602017-08-02
20187207000164Andwin ScientificAndwin Scientific2301522017-08-02
20187207000171Andwin ScientificAndwin Scientific2300402017-08-02
20187207000188Andwin ScientificAndwin Scientific2310482017-08-02
20187207000195Andwin ScientificAndwin Scientific2400802017-08-02
00382904901042BD PrepStain Slide ProcessorTRIPATH IMAGING, INC.4901042015-07-22
00382904904104BD PrepStain Slide ProcessorTRIPATH IMAGING, INC.4904102015-07-22
00382904905071BD SurePathTRIPATH IMAGING, INC.4905072015-07-22
00382904905217BD PrepStainTRIPATH IMAGING, INC.4905212015-07-22
00382904905231BD PrepStainTRIPATH IMAGING, INC.4905232015-07-22
00382904905286BD PrepStainTRIPATH IMAGING, INC.4905282015-07-22
00382904905408BD SurePathTRIPATH IMAGING, INC.4905402015-07-22
00382904905415BD SurePathTRIPATH IMAGING, INC.4905412015-07-22
00382904909857BD PrepStain Slide ProcessorTRIPATH IMAGING, INC.4909852015-07-22
00382904910952BD SurePathBECTON, DICKINSON AND COMPANY4910952015-07-22
00382904910969BD SurePathBECTON, DICKINSON AND COMPANY4910962015-07-22
00382904910976BD SurePathBECTON, DICKINSON AND COMPANY4910972015-07-23
00382904912475BD SurePathTRIPATH IMAGING, INC.4912472017-09-08
00382904912666BD SurePath™ Manual Method KitBECTON, DICKINSON AND COMPANY4912662017-09-08
00382904912673BD PrepStain™ Slide Library KitBECTON, DICKINSON AND COMPANY4912672017-09-08
00382904912888BD PrepMate™ Installation KitBECTON, DICKINSON AND COMPANY4912882017-09-08
00382904912895BD PrepStain™ Install KitBECTON, DICKINSON AND COMPANY4912892017-09-08
00382904913069BD Density ReagentTRIPATH IMAGING, INC.4913062017-09-08
00382904913083BD Totalys™ SlidePrep Consumables KitTRIPATH IMAGING, INC.4913082016-06-23
00382904913106BD Totalys™ MultiProcessor Consumables KitTRIPATH IMAGING, INC.4913102016-06-23
00382904913113BD PrepStain™ Consumables KitTRIPATH IMAGING, INC.4913112017-09-08
00382904913137BD PrepMate™ Consumables KitTRIPATH IMAGING, INC.4913132017-09-08
00382904913885BD Totalys™ SlidePrep Slide Library KitTRIPATH IMAGING, INC.4913882016-06-23
00382904913892BD Totalys™ MultiProcessor Installation KitBECTON, DICKINSON AND COMPANY4913892016-06-23
00382904914387BD SurePath™ GYN Preservative Vial Kit with Cervex-BrushBECTON, DICKINSON AND COMPANY4914382016-06-23
00382904914394BD SurePath™ GYN Preservative Vial Kit with Cervex-Brush CombiBECTON, DICKINSON AND COMPANY4914392016-06-23
00382904914400BD SurePath™ GYN Preservative Vial Kit with Brush/SpatulaBECTON, DICKINSON AND COMPANY4914402016-06-23
00382904914530BD Totalys™ MultiProcessor Consumables KitBECTON, DICKINSON AND COMPANY4914532018-08-22
00382904914547BD PrepStain™ Consumables KitBECTON, DICKINSON AND COMPANY4914542018-08-22