BD PrepStain 490528

GUDID 00382904905286

PrepStain® Install Kit

TRIPATH IMAGING, INC.

Papanicolaou smear kit Papanicolaou smear kit
Primary Device ID00382904905286
NIH Device Record Keyb35da8cb-382b-4601-9140-bfa9900648c7
Commercial Distribution Discontinuation2015-08-26
Commercial Distribution StatusNot in Commercial Distribution
Brand NameBD PrepStain
Version Model Number490528
Catalog Number490528
Company DUNS103318015
Company NameTRIPATH IMAGING, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-663-8663
Emailtechnical_services@bd.com
Phone1-800-663-8663
Emailtechnical_services@bd.com

Device Dimensions

Length53.5 Centimeter
Length53.5 Centimeter
Length53.5 Centimeter
Height54 Centimeter
Width52 Centimeter
Length53.5 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904905286 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MKQProcessor, Cervical Cytology Slide, Automated

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-07-22

On-Brand Devices [BD PrepStain]

00382904905286PrepStain® Install Kit
00382904905231PrepStain® GYN Cytology Test Kit
00382904905217PrepStain® Density Reagent

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