MONOLISA™

Basic Information

• Brand Name: MONOLISA™
• Primary DI: 00847865002097
• Version / Model: 26154
• Catalog Number: 26154
• Company Name: Bio-RAD Laboratories, Inc.
• Labeler DUNS: 844766394
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-08-22
• Public Version: 7
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: ae278edf-d4ae-44b2-b503-a181b7fc9b76

Device Description

Anti-HBs EIA, 10 mIU/mL Calibrator 1.8 mL

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• 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
41997	Hepatitis B virus surface total antibody IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to the Hepatitis B virus surface in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847865002097	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
P050048	000

Device Sizes

Type	Value	Unit	Text
Total Volume	1.8	Milliliter

Storage Conditions

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