LupoTek KCT

Basic Information

• Brand Name: LupoTek KCT
• Primary DI: 10859394006146
• Version / Model: 87-305
• Catalog Number: 87-305
• Company Name: R 2 DIAGNOSTICS, INC.
• Labeler DUNS: 956610125
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-11-15
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 615df66c-7dc0-4529-8e6d-5eb6203a1bdd

Device Description

Screening test for LA 250 DET

Device Characteristics

• Single Use: Yes
• 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
GGW	Test, Time, Partial Thromboplastin	Hematology	864.7925	2

GMDN Terms

Code	Name	Definition	Implantable	Status
56202	Lupus anticoagulant marker IVD, kit, clotting	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple Lupus anticoagulant markers in a clinical specimen, using a clotting method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10859394006146	GS1
Unit of Use	00859394006149	GS1

Premarket Submissions

Submission Number	Supplement Number
K090105	000