FDA.reportPublic FDA data

ThinPrep

Primary DI
15420045513860
Brand
ThinPrep
Company
Hologic, Inc.
Model
ThinPrep Genesis Processor
Catalog number
PRD-04573
Device description
Processes liquid based cytologic specimens to produce a uniform layer of cells on a glass microsope slide. It can also remove an aliquot from a specimen preserved in PreservCyt®.
Published
2024-05-20
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
MKQProcessor, cervical cytology slide, automated

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950039040

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950039040THINPREP(R) PROCESSOR, MODEL TP 2000Hologic, Inc.1996-05-20MKQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15420045513860PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1542004551386015420045513860

GMDN Terms#

Term, Definition table
TermDefinition
Microscope slide maker IVDAn automated mains electricity (AC-powered) laboratory instrument intended to be used to prepare, transfer and/or fix blood, tissue or other clinical specimens onto microscope examination slides so they are suitable for subsequent staining and/or microscopic analysis. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature16 Degrees Celsius32 Degrees Celsius
Storage Environment Temperature-28 Degrees Celsius50 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)442-9892CustomerSupport@hologic.com

Regulatory Flags#

DUNS number
018925968
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05420045503888SecurMarkSMARK-U-SS1SMARK-U-SS12015-09-04
05420045503895SecurMarkSMARK-U-SS2SMARK-U-SS22015-09-04
05420045503901SecurMarkSMARK-U-SS3SMARK-U-SS32015-09-04
15420045511859Unifi WorkspaceUnifi Workspace V1.02019-08-09
15420045515307Acessa ProVu System710071002023-05-16
15420045515314Acessa ProVu SystemMS-06-0171MS-06-01712023-05-16
15420045515284Acessa ProVu System520052002022-11-08
15420045513983BioZorbF0202F02022021-04-21
15420045513990BioZorbF0203F02032021-04-21
15420045514003BioZorbF0303F03032021-04-21
15420045514010BioZorbF0304F03042021-04-21
15420045514027BioZorbF0221F02212021-04-21
15420045514034BioZorbF0231F02312021-04-21
15420045514041BioZorbF0331F03312021-04-21
15420045514058BioZorbF0404F04042021-04-21
15420045514065BioZorbF0405F04052021-04-21
15420045512634Unifi WorkspaceUnifi Workspace V1.02020-09-21
15420045500020Selenia Dimensions C-View SoftwareC-ViewSW-030522014-09-05
15420045504561ATEC IntroducerAI090920AI0909202016-08-11
15420045504578ATEC IntroducerAI091220AI0912202016-08-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00382904913328BD Density Reagent (480 ml)BECTON, DICKINSON AND COMPANYMKQ2017-09-08