HE4 EIA

GUDID 17350066140326

Human epididymis protein 4 (HE4) IVD, kit, chemiluminescent immunoassay

Primary Device ID	17350066140326
NIH Device Record Key	5eac764a-1897-482b-9acb-e0471ce48e8f
Commercial Distribution Status	In Commercial Distribution
Brand Name	HE4 EIA
Version Model Number	404-10US
Company DUNS	357159631
Company Name	Fujirebio Diagnostics AB
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	false
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	true
OTC Over-The-Counter	false

Device Size Text, specify	0
Device Size Text, specify	0

Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Handling Environment Temperature	Between 20 Degrees Celsius and 25 Degrees Celsius

Device Issuing Agency	Device ID
GS1	17350066140326 [Primary]

OIU	Test, Epithelial Ovarian Tumor Associated Antigen (He4)

Steralize Prior To Use	false
Device Is Sterile	false