Coxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System CB-3306

GUDID B110CB33060

Bion Enterprises, Ltd.

Coxsackie B virus immunoglobulin G (IgG) antibody IVD, reagent
Primary Device IDB110CB33060
NIH Device Record Key21e411b0-4e68-426a-b667-103f260ea5a2
Commercial Distribution StatusIn Commercial Distribution
Brand NameCoxsackie B1-6 Screen Virus Antigen Substrate, 6 wells, For IFA Test System
Version Model NumberCB-3306
Catalog NumberCB-3306
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 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
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com
Phone847-544-5044
Emailbion@mblintl.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB110CB33060 [Primary]

FDA Product Code

GNNAntisera, Neutralization, Coxsackievirus A 1-24, B 1-6

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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B110AN10060 - Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System2020-03-04
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