Elecsys Anti-HBs Immunoassay 11820524160

GUDID 04015630919420

Hepatitis B virus surface total antibody IVD, kit, chemiluminescent immunoassay

Primary Device ID	04015630919420
NIH Device Record Key	12b5e3ad-e316-4b7e-89f1-f4f5c145e0d3
Commercial Distribution Discontinuation	2019-06-30
Commercial Distribution Status	Not in Commercial Distribution
Brand Name	Elecsys Anti-HBs Immunoassay
Version Model Number	11820524160
Catalog Number	11820524160
Company DUNS	315028860
Company Name	Roche Diagnostics GmbH
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	false
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	true
OTC Over-The-Counter	false

Storage Environment Temperature

Between 2 Degrees Celsius and 8 Degrees Celsius

Device Issuing Agency	Device ID
GS1	04015630919420 [Primary]

LOM	Test, hepatitis b (b core, be antigen, be antibody, b core igm)

Steralize Prior To Use	false
Device Is Sterile	false