West Nile Virus IgG DxSelect™

GUDID 20816101022001

DIASORIN MOLECULAR LLC

West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) West Nile virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID20816101022001
NIH Device Record Key5474e88c-ef29-4bdd-bc43-6a0969e6a185
Commercial Distribution StatusIn Commercial Distribution
Brand NameWest Nile Virus IgG DxSelect™
Version Model NumberEL0300G
Company DUNS080271715
Company NameDIASORIN MOLECULAR LLC
Device Count1
DM Exemptfalse
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone562-240-6500
EmailDxTs@focusdx.com
Phone562-240-6500
EmailDxTs@focusdx.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS120816101022001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NOPElisa, Antibody, West Nile Virus

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 Date2016-09-22

On-Brand Devices [West Nile Virus IgG DxSelect™]

20816101022018EL0300G-5
20816101022001EL0300G

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