Echovirus IgG Control ECG-4420

GUDID B110ECG44200

Multiple enterovirus immunoglobulin G (IgG) antibody IVD, control

Primary Device ID	B110ECG44200
NIH Device Record Key	51d16ab9-ea12-46d2-af02-09deb14d6419
Commercial Distribution Discontinuation	2017-01-30
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Echovirus IgG Control
Version Model Number	ECG-4420
Catalog Number	ECG-4420
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	false
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 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
HIBCC	B110ECG44200 [Primary]

GNI	Antisera, Neutralization, Echovirus 1-34

Steralize Prior To Use	false
Device Is Sterile	false

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