EBV EA 10 Well; 10 pk I-EBV03X

GUDID 00813545025618

SCIMEDX CORPORATION

Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00813545025618
• NIH Device Record Key: fb2c8f1e-709c-40ad-aeff-4edefa6425a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EBV EA 10 Well; 10 pk
• Version Model Number: I-EBV03X
• Catalog Number: I-EBV03X
• Company DUNS: 155424708
• Company Name: SCIMEDX 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18002215598
• Email: service@scimedx.com
• Phone: 18002215598
• Email: service@scimedx.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813545025618 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K992587

FDA Product Code

• LSE: Epstein-Barr Virus, Other

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: 2016-09-20

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