West Nile Virus IgG DxSelect™ - IgG Antigen Wells EL0351

GUDID 10816101022349

DIASORIN MOLECULAR LLC

West Nile virus immunoglobulin G (IgG) antibody IVD, reagent
Primary Device ID10816101022349
NIH Device Record Key47e3d6e3-2b93-48a4-9101-20d49b7c342b
Commercial Distribution StatusIn Commercial Distribution
Brand NameWest Nile Virus IgG DxSelect™ - IgG Antigen Wells
Version Model NumberEL0351
Catalog NumberEL0351
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 Kitfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.com
Phone562-240-6500
Emailts.molecular@diasorin.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
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
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
GS110816101022349 [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 Number4
Public Version Date2024-07-08
Device Publish Date2017-07-11

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20816101027211 - Simplexa™ C. auris Positive Control Pack2024-07-29
20816101027235 - Simplexa™ C. auris Sample Prep Kit2024-07-29
10816101022240 - DxSelect™ Amber Sample Diluent2024-07-09
10816101022325 - West Nile Virus IgG DxSelect™ IgG Cutoff Calibrator2024-07-08
10816101022332 - West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control2024-07-08

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