PreciControl Anti-HBe

Basic Information

• Brand Name: PreciControl Anti-HBe
• Primary DI: 04015630938872
• Version / Model: 11876384160
• Catalog Number: 11876384160
• Company Name: Roche Diagnostics GmbH
• Labeler DUNS: 315028860
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-07
• Public Version: 3
• Public Version Date: 2022-01-25
• Public Version Status: Update
• Public Device Record Key: 4f8d898c-2750-4ce3-a612-c2a78b89e1c5

Device Description

Anti-HBe PC Elecsys

Device Characteristics

• Single Use: No
• 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
42025	Hepatitis E virus total antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis E virus in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04015630938872	GS1

Premarket Submissions

Submission Number	Supplement Number
P190005	000
P190005	001