REAADS Coagulation Control 1 701-001

GUDID 00855360006243

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.

CORGENIX MEDICAL CORPORATION

Multiple coagulation factor IVD, control

• Primary Device ID: 00855360006243
• NIH Device Record Key: d8d07825-4944-4015-a0b9-7faebd5b40ca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: REAADS Coagulation Control 1
• Version Model Number: 701-001
• Catalog Number: 701-001
• Company DUNS: 619834542
• Company Name: CORGENIX MEDICAL CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-729-5661
• Email: technicalsupport@corgenix.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00855360006243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941737

FDA Product Code

• GIZ: Plasma, Control, Normal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-07-14

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