VIDAS® Mumps IgG

Basic Information

• Brand Name: VIDAS® Mumps IgG
• Primary DI: 03573026064525
• Version / Model: 30218
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-09-16
• Public Version: 1
• Public Version Date: 2019-09-24
• Public Version Status: New
• Public Device Record Key: 48cff733-d406-43c4-b8a3-02afd5973f70

Device Description

VIDAS Mumps IgG (MPG) is qualitative test for use on s VIDAS family instruments for the detection of IgG antibodies to mumps virus

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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
LJY	ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS	Microbiology	866.3380	1

GMDN Terms

Code	Name	Definition	Implantable	Status
49332	Mumps virus immunoglobulin G (IgG) antibody 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 immunoglobulin G (IgG) antibodies to Mumps virus 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	03573026064525	GS1

Premarket Submissions

Submission Number	Supplement Number
K923903	000

Storage Conditions

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