BD Onclarity™ 444088

GUDID 00382904440886

Control Set for the BD Onclarity™ HPV Assay

BECTON, DICKINSON AND COMPANY

Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00382904440886
NIH Device Record Key3deee98b-2d45-4c6f-b8ad-4f24e2740ed6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Onclarity™
Version Model Number444088
Catalog Number444088
Company DUNS122561087
Company NameBECTON, DICKINSON AND COMPANY
Device Count1
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
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com
Phone+1(800)638-8663
EmailTechnical_services@bd.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 33 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904440886 [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 Date2021-04-02
Device Publish Date2021-03-25

Devices Manufactured by BECTON, DICKINSON AND COMPANY

00382903364916 - BD FACS™2024-03-27 BD FACS™ Lyse Wash Assistant Large External Tank
00382904431594 - BD Pre-warm Heater2024-03-27 KIT PREWARM MAX6
30382903659679 - BD Microtainer® SST™2024-03-27 TUBE MICRO W/MICROGARD SST GLD
30382903678359 - BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes2024-03-27 BD Vacutainer® K2 EDTA 5.4mg
30382903678441 - BD Vacutainer® K2 EDTA (K2E) 7.2mg Blood Collection Tubes2024-03-27 BD Vacutainer® K2 EDTA 7.2mg
30382903678595 - BD Vacutainer® K2 EDTA (K2E) 5.4mg Blood Collection Tubes2024-03-27 TUBE K2EDTA PLH 13X75 3.0 MLBL LAV
30382903678625 - BD Vacutainer® K2 EDTA (K2E) Blood Collection Tubes2024-03-27 TUBE EDTA PLH 13X75 4.0 SLBLCE LAV
30382903678717 - BD Vacutainer® Sodium HeparinN (NH) 75 USP Units Blood Collection Tubes2024-03-27 BD Vacutainer® Sodium Heparin(N) 75 USP Units

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.