Varicella Zoster Negative Control VZN-7010

GUDID B110VZN70100

Bion Enterprises, Ltd.

Varicella-zoster virus (VZV) immunoglobulin M (IgM) antibody IVD, control
Primary Device IDB110VZN70100
NIH Device Record Keye2c5abb6-4e5b-4cc7-a4d0-1cfdbaf1490f
Commercial Distribution StatusIn Commercial Distribution
Brand NameVaricella Zoster Negative Control
Version Model NumberVZN-7010
Catalog NumberVZN-7010
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
HIBCCB110VZN70100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GQWAntigen, Cf, (Including Cf Control), Varicella-Zoster

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-03-04
Device Publish Date2016-09-12

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