ASI EB VCA IgM EIA Test NC-880096-AM

GUDID 00816057020652

Detection of Epstein Barr Viral Capsid Antigen

ARLINGTON SCIENTIFIC, INC.

Epstein-Barr virus (EBV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Primary Device ID00816057020652
NIH Device Record Key7fc3c5a1-f274-43fc-8006-f1a68f7ea4e9
Commercial Distribution StatusIn Commercial Distribution
Brand NameASI EB VCA IgM EIA Test
Version Model NumberNC-880096-AM
Catalog NumberNC-880096-AM
Company DUNS785966607
Company NameARLINGTON SCIENTIFIC, INC.
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

Phone801-489-8911
Emailinfo@arlingtonscientific.com
Phone801-489-8911
Emailinfo@arlingtonscientific.com
Phone801-489-8911
Emailinfo@arlingtonscientific.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100816057020652 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJNAntibody Igm, If, Epstein-Barr Virus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-21
Device Publish Date2016-07-08

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