VIDAS® TOXO Compétition

Basic Information

• Brand Name: VIDAS® TOXO Compétition
• Primary DI: 03573026156862
• Version / Model: 30211-01
• Company Name: BIOMERIEUX SA
• Labeler DUNS: 276816717
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-31
• Public Version: 3
• Public Version Date: 2022-02-02
• Public Version Status: Update
• Public Device Record Key: b25f9b36-903f-4aba-b1f1-f47d598e8ecc
• Distribution End Date: 2020-12-31

Device Description

VIDAS ® TOXO Competition assay is an automated qualitative IA intended for use on VIDAS family instrument for the screening of total anti - Toxoplasma 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
52444	Toxoplasma gondii total 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 total 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	03573026156862	GS1

Storage Conditions

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