ACCURUN®

Basic Information

• Brand Name: ACCURUN®
• Primary DI: 00816784020390
• Version / Model: 2015-0082
• Catalog Number: 2015-0082
• Company Name: Lgc Clinical Diagnostics, Inc.
• Labeler DUNS: 106267123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 5
• Public Version Date: 2023-07-25
• Public Version Status: Update
• Public Device Record Key: 87a13d31-e69a-40c3-9859-be934046ac3d

Device Description

ACCURUN 135 Toxoplasma IgG 1 x 1.0 mL

Device Characteristics

• Single Use: No
• 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
LJK	Antisera, If, Toxoplasma Gondii	Microbiology	866.3780	2

GMDN Terms

Code	Name	Definition	Implantable	Status
42167	Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to the parasitic protozoan Toxoplasma gondii in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816784020390	GS1

Premarket Submissions

Submission Number	Supplement Number
K974261	000

Storage Conditions

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