ACCURUN® 365 Series 200

Basic Information

• Brand Name: ACCURUN® 365 Series 200
• Primary DI: 00816784020901
• Version / Model: 2020-0107
• Catalog Number: 2020-0107
• Company Name: Lgc Clinical Diagnostics, Inc.
• Labeler DUNS: 106267123
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-24
• Public Version: 2
• Public Version Date: 2022-03-28
• Public Version Status: Update
• Public Device Record Key: fb29cb44-16c2-4e15-a426-4af96d52c9b4

Device Description

ACCURUN® 365 Series 200 West Nile Virus Positive Control 10 x 1.5 mL per vial.

Device Characteristics

• Single Use: Yes
• 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
MYZ	Kit, Test (Donors), For Bloodborne Pathogen	Unknown		2

GMDN Terms

Code	Name	Definition	Implantable	Status
49047	West Nile virus nucleic acid 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 nucleic acid from West Nile virus in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816784020901	GS1

Premarket Submissions

Submission Number	Supplement Number
BK060022	0

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -80 – -65 Degrees Celsius