West Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control EL0311

GUDID 10816101022332

DIASORIN MOLECULAR LLC

West Nile virus immunoglobulin G (IgG) antibody IVD, control
Primary Device ID10816101022332
NIH Device Record Keyef13d58a-c7a1-493a-950f-6015ceaa857b
Commercial Distribution StatusIn Commercial Distribution
Brand NameWest Nile Virus IgG Positive Control DxSelect™ - IgG Positive Control
Version Model NumberEL0311
Catalog NumberEL0311
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
GS110816101022332 [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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10816101027290 - Human GAPDH Endogenous Primer Pair2024-08-30
20816101027198 - Simplexa™ C. auris Direct2024-07-29
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

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