REAADS Coagulation Control 1

Basic Information

• Brand Name: REAADS Coagulation Control 1
• Primary DI: 00855360006243
• Version / Model: 701-001
• Catalog Number: 701-001
• Company Name: CORGENIX MEDICAL CORPORATION
• Labeler DUNS: 619834542
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-14
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d8d07825-4944-4015-a0b9-7faebd5b40ca

Device Description

REAADS Coagulation Control 1 (CC-1) is an assayed control plasma in coagulation studies for In Vitro Diagnostic Use. PRINCIPLE OF THE PROCEDURE Coagulation Control 1 is tested in the same manner as citrated patient plasma samples to assess the performance of each assay run, for the parameters. Testing variables in each laboratory, including equipment, reagents, and technique may influence control recovery. Although an expected range is provided for each parameter, laboratories should establish their own expected range for their particular instrument-reagent system. Refer to Package Insert.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
GIZ	Plasma, Control, Normal	Hematology	864.5425	2

GMDN Terms

Code	Name	Definition	Implantable	Status
30590	Multiple coagulation factor IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of one or multiple coagulation factors, coagulation intermediates and/or their activated components in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00855360006243	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K941737	000

Storage Conditions

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