BD Onclarity HPV Self Collection Diluent Tube 445416

GUDID 00382904454166

BD Onclarity HPV Self Collection Diluent Tube

BECTON, DICKINSON AND COMPANY

Human papillomavirus (HPV) nucleic acid IVD, reagent
Primary Device ID00382904454166
NIH Device Record Key3d0619ff-933d-42ce-85a6-37af408c785f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Onclarity HPV Self Collection Diluent Tube
Version Model Number445416
Catalog Number445416
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
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100382904454166 [Unit of Use]
GS130382904454167 [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 Date2024-11-11
Device Publish Date2024-11-01

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60382904454755 - BD BACTEC™ 92402024-11-12 BD BACTEC™ 9240
60382904455707 - BD BACTEC™ 91202024-11-12 BD BACTEC™ 9120
00382904458003 - BD BACTEC™ 90502024-11-11 BD BACTEC™ 9050
00382904454166 - BD Onclarity HPV Self Collection Diluent Tube2024-11-11BD Onclarity HPV Self Collection Diluent Tube
00382904454166 - BD Onclarity HPV Self Collection Diluent Tube2024-11-11 BD Onclarity HPV Self Collection Diluent Tube
00382906639844 - Horizon2024-10-22 CD138 (MI15) BV421 ASR
00382906651204 - Horizon2024-10-22 CD197 (2-L1-A) APC-R700 ASR
00382906651297 - Horizon2024-10-22 CD194 (1G1) BV421 ASR

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