Adenovirus Antigen Substrate, 12 wells, For IFA Test System AD-3112

GUDID B110AD31120

Adenovirus immunoglobulin G (IgG) antibody IVD, reagent

Primary Device ID	B110AD31120
NIH Device Record Key	b9b435d0-af8b-4955-a033-da1267c79e55
Commercial Distribution Status	In Commercial Distribution
Brand Name	Adenovirus Antigen Substrate, 12 wells, For IFA Test System
Version Model Number	AD-3112
Catalog Number	AD-3112
Company DUNS	024824641
Company Name	Bion Enterprises, Ltd.
Device Count	1
DM Exempt	false
Pre-market Exempt	true
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Storage Environment Temperature	Between 0 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 0 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	B110AD31120 [Primary]

GNY	Antisera, Fluorescent, Adenovirus 1-33

Steralize Prior To Use	false
Device Is Sterile	false

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