BD Veritor™ System For Rapid Detection of RSV - Laboratory kit 256042

GUDID 00382902560425

BD Veritor™ System For Rapid Detection of RSV Contains: 30 Reactive strips, 30 RV Reagent C in unitized tubes, 30 plastic transfer pipettes, and one each of RSV+ Control, RSV - Control

BECTON, DICKINSON AND COMPANY

Respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT) Respiratory syncytial virus (RSV) antigen IVD, kit, immunochromatographic test (ICT) Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical Respiratory syncytial virus (RSV) antigen IVD, kit, rapid ICT, clinical
Primary Device ID00382902560425
NIH Device Record Keya02d40f5-fd79-4a09-a8f4-da3fd71caf3c
Commercial Distribution StatusIn Commercial Distribution
Brand NameBD Veritor™ System For Rapid Detection of RSV - Laboratory kit
Version Model Number256042
Catalog Number256042
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
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 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100382902560425 [Primary]
GS105032902560424 [Package]
Package: Case [12 Units]
In Commercial Distribution

FDA Product Code

GQGANTIGEN, CF (INCLUDING CF CONTROLS), RESPIRATORY SYNCYTIAL VIRUS

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-06-25
Device Publish Date2018-05-25

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