VIDAS® TOXO IgM

Basic Information

• Brand Name: VIDAS® TOXO IgM
• Primary DI: 03573026156824
• Version / Model: 30202-01
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 46143f07-f203-4f28-b848-f6b92c0feed1

Device Description

TOXO IgM (TXM) assay is a qualitative IA intended for use on VIDAS family instrument in the detection of anti - toxoplasma IgG concentration in human serum or plasma.

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
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	866.3780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
52440	Toxoplasma gondii immunoglobulin M (IgM) 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 M (IgM) antibodies to the parasitic protozoan Toxoplasma gondii 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	03573026156824	GS1

Premarket Submissions

Submission Number	Supplement Number
K141133	000

Storage Conditions

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