Varicella Zoster Virus Antigen Control Slide, 2 wells QVZ-7002

GUDID B110QVZ70020

Bion Enterprises, Ltd.

Varicella-zoster virus (VZV) antigen IVD, control Varicella-zoster virus (VZV) antigen IVD, control
Primary Device IDB110QVZ70020
NIH Device Record Key1e305500-8500-4b29-b25f-a06e35d6b46c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVaricella Zoster Virus Antigen Control Slide, 2 wells
Version Model NumberQVZ-7002
Catalog NumberQVZ-7002
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 Usetrue
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 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB110QVZ70020 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJGQuality Control Slides

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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