EBV Negative Control EBN-5010

GUDID B110EBN50100

Bion Enterprises, Ltd.

Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, control
Primary Device IDB110EBN50100
NIH Device Record Key17e57ea6-3f14-4c49-bc0d-9e4913504ba9
Commercial Distribution StatusIn Commercial Distribution
Brand NameEBV Negative Control
Version Model NumberEBN-5010
Catalog NumberEBN-5010
Company DUNS024824641
Company NameBion Enterprises, Ltd.
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

Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.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
HIBCCB110EBN50100 [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 Number5
Public Version Date2020-03-04
Device Publish Date2016-09-12

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