Anti-ß2-Glycoprotein 1 ELISA (IgG)

GUDID 04049016027195

Beta-2-glycoprotein I antibody IVD, kit, enzyme immunoassay (EIA)

Primary Device ID	04049016027195
NIH Device Record Key	834f8450-484a-4c97-b2f2-96582a0cb3ca
Commercial Distribution Discontinuation	2017-09-11
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Anti-ß2-Glycoprotein 1 ELISA (IgG)
Version Model Number	EA 1632-9601 G
Company DUNS	322209263
Company Name	EUROIMMUN Medizinische Labordiagnostika AG
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	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

Device Issuing Agency	Device ID
GS1	04049016027195 [Primary]

DDN	Beta-2-Glycoprotein I, Antigen, Antiserum, Control

Steralize Prior To Use	false
Device Is Sterile	false