MONOLISA™

Basic Information

• Brand Name: MONOLISA™
• Primary DI: 00847865013130
• Version / Model: 26199
• Catalog Number: 26199
• 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: b4e95c40-7468-414f-8423-be6182b73dbb

Device Description

Anti-HBc IgM EIA, Specimen Diluent, 30 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
48299	Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of immunoglobulin M (IgM) antibodies to the Hepatitis B virus core antigen in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00847865013130	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P060034	000

Device Sizes

Type	Value	Unit	Text
Total Volume	30	Milliliter

Storage Conditions

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