ASI SLE Slide Test NC-350050

GUDID 00816057020218

Detection of Anti-DNP, associated with Systemic Lupus Erythematosus

ARLINGTON SCIENTIFIC, INC.

Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, reagent

• Primary Device ID: 00816057020218
• NIH Device Record Key: 2b6da645-066e-4106-a36c-c44948e2f4b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ASI SLE Slide Test
• Version Model Number: NC-350050
• Catalog Number: NC-350050
• 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	00816057020218 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K821385

FDA Product Code

• DHC: System, Test, Systemic Lupus Erythematosus

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 SLE Slide Test]

• 00816057020256: Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
• 00816057020249: Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export
• 00816057020232: Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
• 00816057020225: Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export
• 00816057020218: Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
• 00816057020201: Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export
• 00816057020195: Detection of Anti-DNP, associated with Systemic Lupus Erythematosus