HSV-2 ELISA IgG High Positive Control EL0908

GUDID 10816101022127

DIASORIN MOLECULAR LLC

Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, control
Primary Device ID10816101022127
NIH Device Record Key1c3ec2e0-0a5d-43ee-8489-94a13748ebea
Commercial Distribution StatusIn Commercial Distribution
Brand NameHSV-2 ELISA IgG High Positive Control
Version Model NumberEL0908
Catalog NumberEL0908
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
GS110816101022127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MYFEnzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-04
Device Publish Date2016-09-22

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