BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes 443837

GUDID 00382904438371

BD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes

BECTON, DICKINSON AND COMPANY

Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00382904438371
NIH Device Record Keyab8c5d44-1775-4099-a2da-268efa7b6bc2
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Onclarity™ HPV Liquid Based Cytology Specimen (LBC) Diluent Tubes
Version Model Number443837
Catalog Number443837
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count400
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)638-8663
EmailTechnical_services@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904438371 [Unit of Use]
GS130382904438372 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAQKIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-27
Device Publish Date2020-02-19

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Trademark Results [BD Onclarity]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BD ONCLARITY
BD ONCLARITY
87248678 5649839 Live/Registered
Becton, Dickinson and Company
2016-11-28
BD ONCLARITY
BD ONCLARITY
85917455 not registered Dead/Abandoned
Becton, Dickinson and Company
2013-04-29
BD ONCLARITY
BD ONCLARITY
85236664 not registered Dead/Abandoned
Becton, Dickinson and Company
2011-02-08
BD ONCLARITY
BD ONCLARITY
85236650 not registered Dead/Abandoned
Becton, Dickinson and Company
2011-02-08
BD ONCLARITY
BD ONCLARITY
85236642 not registered Dead/Abandoned
Becton, Dickinson and Company
2011-02-08

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