AccuDiag™ Estradiol ELISA 2046-15

GUDID 00850054026682

Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	00850054026682
NIH Device Record Key	f3b4f8bf-77b5-4cd8-ac20-6c1dcd7d1b1e
Commercial Distribution Status	In Commercial Distribution
Brand Name	AccuDiag™ Estradiol ELISA
Version Model Number	DACD2046-15
Catalog Number	2046-15
Company DUNS	878252071
Company Name	Diagnostic Automation, 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	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	false
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
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment Temperature	Between 2 Degrees Celsius and 8 Degrees Celsius
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
GS1	00850054026682 [Primary]

CHP	Radioimmunoassay, Estradiol

Steralize Prior To Use	false
Device Is Sterile	false

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Mark Image Registration \| Serial	Company Trademark Application Date
ACCUDIAG 85042566 4091726 Live/Registered	Diagnostic Automation, Inc. 2010-05-19