MONOLISA™

Basic Information

• Brand Name: MONOLISA™
• Primary DI: 00847865011372
• Version / Model: 26186
• Catalog Number: 26186
• 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: 8
• Public Version Date: 2023-01-31
• Public Version Status: Update
• Public Device Record Key: 14614b9b-9da7-42dc-a82a-4ca000ea1f3c

Device Description

MONOLISA™ Anti-HBc EIA 192 Tests

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• 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
48293	Hepatitis B virus core antigen IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of Hepatitis B virus core antigen in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847865011372	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P060031	000
P060031	007

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			192 tests

Storage Conditions

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