Adenovirus IgG Control ADG-3120

GUDID B110ADG31200

Bion Enterprises, Ltd.

Adenovirus immunoglobulin G (IgG) antibody IVD, control Adenovirus immunoglobulin G (IgG) antibody IVD, control
Primary Device IDB110ADG31200
NIH Device Record Key16c5c691-625c-4c93-9645-df93ce4303d9
Commercial Distribution Discontinuation2017-01-30
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAdenovirus IgG Control
Version Model NumberADG-3120
Catalog NumberADG-3120
Company DUNS024824641
Company NameBion Enterprises, Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
HIBCCB110ADG31200 [Primary]

FDA Product Code

GNYAntisera, Fluorescent, Adenovirus 1-33

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2020-03-04
Device Publish Date2016-09-12

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