PreciControl Rubella IgM 4618840190

GUDID 04015630921478

Roche Diagnostics GmbH

Rubella virus immunoglobulin M (IgM) antibody IVD, control

• Primary Device ID: 04015630921478
• NIH Device Record Key: a07303d3-ba95-47a4-8b52-e74aeb0b24f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreciControl Rubella IgM
• Version Model Number: 4618840190
• Catalog Number: 4618840190
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630921478 [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: 2021-01-26
• Device Publish Date: 2021-01-18

On-Brand Devices [PreciControl Rubella IgM]

• 04015630921478: 4618840190
• 07613336220108: 09787518190