PreciControl Anti-CMV 04784600162

GUDID 07613336183151

Roche Diagnostics GmbH

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control

• Primary Device ID: 07613336183151
• NIH Device Record Key: b44e6a08-26e4-403e-860a-c04c6756ef03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreciControl Anti-CMV
• Version Model Number: 04784600162
• Catalog Number: 04784600162
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613336183151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK230840

FDA Product Code

• MZE: Test, donor, CMV

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: 2023-12-13
• Device Publish Date: 2023-12-05

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• 07613336230671 - Elecsys sFlT-1: 2025-04-15
• 07613336230756 - Elecsys PlGF: 2025-04-15
• 07613336223321 - Kidney KFRE Algorithm: 2025-04-08