ACCURUN®

Basic Information

• Brand Name: ACCURUN®
• Primary DI: 00816784020215
• Version / Model: 2010-0013
• Catalog Number: 2010-0013
• 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: 545fe54a-7e4e-4959-b1ed-f31a503eb6cc

Device Description

ACCURUN 1 Multi-Marker Negative Control 1 x 5.0 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
KSF	Kit, Quality Control For Blood Banking Reagents	Hematology	864.9650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
57776	Negative control immunoglobulin IVD	A material containing immunoglobulin intended to be used in place of a primary antibody as a negative control to verify the performance of an assay that utilizes antibodies (e.g., immunoassay, immunohistochemistry or flow cytometry) and is performed on biological tissues or clinical specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00816784020215	GS1

Premarket Submissions

Submission Number	Supplement Number
BK010038	0

Device Sizes

Type	Value	Unit	Text
Total Volume	5	Milliliter

Storage Conditions

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