STRATIFY JCV™ DXSELECT™

GUDID 20816101022254

DIASORIN MOLECULAR LLC

JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA) JC virus (JCV) antigen IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 20816101022254
• NIH Device Record Key: c71277c1-24b9-4800-a079-c458a601ad42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STRATIFY JCV™ DXSELECT™
• Version Model Number: EL1950
• Company DUNS: 080271715
• Company Name: DIASORIN MOLECULAR LLC
• 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: 562-240-6500
• Email: DxTs@focusdx.com
• Phone: 562-240-6500
• Email: DxTs@focusdx.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	20816101022254 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120986

FDA Product Code

• OYP: Anti-Jcv Antibody Detection Assay

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: 2016-09-22

On-Brand Devices [STRATIFY JCV™ DXSELECT™]

• 20816101022261: EL1950-5
• 20816101022254: EL1950