ASI Color Mono II Test NC-4501000

GUDID 00816057020324

Detection of heterophil antibodies associated with infectious mononucleosis

ARLINGTON SCIENTIFIC, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination

• Primary Device ID: 00816057020324
• NIH Device Record Key: 3bc9972b-105c-4cdc-a8eb-be7de0bb4c9a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASI Color Mono II Test
• Version Model Number: NC-4501000
• Catalog Number: NC-4501000
• Company DUNS: 785966607
• Company Name: ARLINGTON SCIENTIFIC, INC.
• 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: true
• Device Combination Product: false
• Single Use: false
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 801-489-8911
• Email: info@arlingtonscientific.com
• Phone: 801-489-8911
• Email: info@arlingtonscientific.com
• Phone: 801-489-8911
• Email: info@arlingtonscientific.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816057020324 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K821386

FDA Product Code

• KTN: System, Test, Infectious Mononucleosis

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: 2016-07-08

On-Brand Devices [ASI Color Mono II Test]

• 00816057020324: Detection of heterophil antibodies associated with infectious mononucleosis
• 00816057020317: Detection of heterophil antibodies associated with infectious mononucleosis, Export
• 00816057020300: Detection of heterophil antibodies associated with infectious mononucleosis
• 00816057020294: Detection of heterophil antibodies associated with infectious mononucleosis, Export
• 00816057020287: Detection of heterophil antibodies associated with infectious mononucleosis
• 00816057020270: Detection of heterophil antibodies associated with infectious mononucleosis, Export
• 00816057020263: Detection of heterophil antibodies associated with infectious mononucleosis