TRIPATH IMAGING, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Processor, Cervical Cytology Slide, Automated (MKQ) (8) Spatula, Cervical, Cytological (HHT) (2)

Premarket Exempt

Clear

BD Density Reagent - 00382904913069 Catalog Number : 491306

Device Description : BD Density Reagent (1900mL)

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD Totalys™ SlidePrep Consumables Kit - 00382904913083 Catalog Number : 491308

Device Description : BD Totalys™ SlidePrep Consumables Kit

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD Totalys™ MultiProcessor Consumables Kit - 00382904913106 Catalog Number : 491310

Device Description : BD Totalys™ MultiProcessor Consumables Kit

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD PrepStain™ Consumables Kit - 00382904913113 Catalog Number : 491311

Device Description : BD PrepStain™ Consumables Kit: BD SurePath™ PreCoat Slides (5 X 96), BD PrepSta BD PrepStain™ Consumables Kit: BD SurePath™ PreCoat Slides (5 X 96), BD PrepStain™ Transfer Tips (5 X 96), & BD Settling Chambers (2 X 240)

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD PrepMate™ Consumables Kit - 00382904913137 Catalog Number : 491313

Device Description : BD PrepMate™ Consumables Kit

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD Totalys™ SlidePrep Slide Library Kit - 00382904913885 Catalog Number : 491388

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

ROVERS® CERVEX-BRUSH® - 10382904905245 Catalog Number : 490524

Device Description : ROVERS® CERVEX-BRUSH®

Device Class :

Duns Number: 103318015

Premarket Exempt : No

Product Code : HHT

Prescription Use : Yes

Device Count : 25

Rovers ® Combo-brush® - 10382904905269 Catalog Number : 490526

Device Description : Rovers ® Cervex-Brush® Combi

Device Class :

Duns Number: 103318015

Premarket Exempt : No

Product Code : HHT

Prescription Use : Yes

Device Count : 25

BD SurePath™ Collection Vial Kit 500 - 10382904912533 Catalog Number : 491253

Device Description : BD SurePath™ Collection Vial Kit 500: BD SurePath™ Collection Vials (500)

Device Class :

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 25

BD SurePath - 30382904905119 Catalog Number : 490511

Device Description : SurePath® PreCoat Slides

Device Class :

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 60

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