Validate

GUDID 00850011135518

Rubella IgG Calibration Verification / Linearity Test Kit

Lgc Clinical Diagnostics, Inc.

Rubella virus immunoglobulin G (IgG) antibody IVD, control

• Primary Device ID: 00850011135518
• NIH Device Record Key: 69c25a99-79f1-427a-85fc-71a4f683b416
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Validate
• Version Model Number: 802re
• Company DUNS: 075886031
• Company Name: Lgc Clinical Diagnostics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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

Operating and Storage Conditions

• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius
• Handling Environment Temperature: Between -25 Degrees Celsius and -10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850011135518 [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: 2022-11-30
• Device Publish Date: 2022-11-22

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