Adenovirus Antigen Control Slide, 2 wells QAD-3102

GUDID B110QAD31020

Bion Enterprises, Ltd.

Adenovirus antigen IVD, control
Primary Device IDB110QAD31020
NIH Device Record Key10f1f5f8-ca1e-4d87-bab7-792cc13e81c0
Commercial Distribution StatusIn Commercial Distribution
Brand NameAdenovirus Antigen Control Slide, 2 wells
Version Model NumberQAD-3102
Catalog NumberQAD-3102
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
HIBCCB110QAD31020 [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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B110ADG31200 - Adenovirus IgG Control2020-03-04
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B110AN10060 - Antinuclear Antibody HEp-2 Antigen Substrate 6 wells, For IFA Test System2020-03-04
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