Elecsys HBsAg Confirmatory Test

Basic Information

• Brand Name: Elecsys HBsAg Confirmatory Test
• Primary DI: 04015630911110
• Version / Model: 11820648122
• Catalog Number: 11820648122
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-10
• Public Version: 4
• Public Version Date: 2020-03-30
• Public Version Status: Update
• Public Device Record Key: 4e8121bf-6568-47ce-bd0e-45c4a493a86f

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOM	Test, hepatitis b (b core, be antigen, be antibody, b core igm)	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60812	Hepatitis B virus surface antigen neutralization IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative neutralization of Hepatitis B virus surface antigens in a clinical specimen, using Hepatitis B virus antibodies of known specificity and a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630911110	GS1

Premarket Submissions

Submission Number	Supplement Number
P160019	000
P160019	001
P160019	003
P160019	004
P160019	010
P990012	000
P990012	001
P990012	005
P990012	006
P990012	012

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius