Henry Schein OneStep 1125547

GUDID 00304040001387

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, immunochromatographic test (ICT), rapid

Primary Device ID	00304040001387
NIH Device Record Key	b48bb5e8-4419-4f9d-aadd-4a3df1121019
Commercial Distribution Status	In Commercial Distribution
Brand Name	Henry Schein OneStep
Version Model Number	1125547
Catalog Number	1125547
Company DUNS	012430880
Company Name	HENRY SCHEIN, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	true
Device Combination Product	true
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	false
OTC Over-The-Counter	false

Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 30 Degrees Celsius

Device Issuing Agency	Device ID
GS1	00304040001387 [Primary]

KTN	SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS

Steralize Prior To Use	false
Device Is Sterile	false