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) (10)

Premarket Exempt

Clear

BD PrepStain Slide Processor - 00382904901042 Catalog Number : 490104

Device Description : BD PrepMate™ Automated Accessory(220V)

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD PrepStain Slide Processor - 00382904904104 Catalog Number : 490410

Device Description : BD PrepMate™ Automated Accessory (115V)

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD SurePath - 00382904905071 Catalog Number : 490507

Device Description : SurePath® Preservative Fluid

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD PrepStain - 00382904905217 Catalog Number : 490521

Device Description : PrepStain® Density Reagent

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD PrepStain - 00382904905231 Catalog Number : 490523

Device Description : PrepStain® GYN Cytology Test Kit

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD PrepStain - 00382904905286 Catalog Number : 490528

Device Description : PrepStain® Install Kit

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD SurePath - 00382904905408 Catalog Number : 490540

Device Description : SurePath® GYN Collection Kit contains 100 collection vials used to preserve, tra SurePath® GYN Collection Kit contains 100 collection vials used to preserve, transport, and store cevical cytology samples.

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD SurePath - 00382904905415 Catalog Number : 490541

Device Description : SurePath® Slide Library Kit

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD PrepStain Slide Processor - 00382904909857 Catalog Number : 490985

Device Description : BD PrepMate™ Instrument 115 v (Refurbished)

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

BD SurePath - 00382904912475 Catalog Number : 491247

Device Description : BD SurePath™ GYN Cytology Test Kit

Device Class : 3

Duns Number: 103318015

Premarket Exempt : No

Product Code : MKQ

Prescription Use : Yes

Device Count : 1

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