ACCURUN® 2 Series 5600

GUDID 00860006589783

Lgc Clinical Diagnostics, Inc.

Multiple blood-borne virus antigen/antibody IVD, control

• Primary Device ID: 00860006589783
• NIH Device Record Key: 4e69e9ee-8d5d-4357-906f-118aadcc1d12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCURUN® 2 Series 5600
• Version Model Number: 2000-0100
• Company DUNS: 106267123
• Company Name: Lgc Clinical Diagnostics, 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006589783 [Primary]

FDA Product Code

• JJX: Single (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-12
• Device Publish Date: 2024-08-02

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