PreciControl HBeAg 11876376160

GUDID 04015630934843

Roche Diagnostics GmbH

Hepatitis B virus e-antigen IVD, control

• Primary Device ID: 04015630934843
• NIH Device Record Key: 78ecb779-4a14-40db-9d3b-579f2460eee2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreciControl HBeAg
• Version Model Number: 11876376160
• Catalog Number: 11876376160
• 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: 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630934843 [Previous]
GS1	07613336154298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P130015

FDA Product Code

• LOM: Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

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: 2018-02-22

Devices Manufactured by Roche Diagnostics GmbH

• 04015630924288 - sFlT-1 CalSet: 2025-04-15
• 04015630925407 - CalSet PlGF: 2025-04-15
• 07613336172094 - Elecsys sFlT-1: 2025-04-15
• 07613336172124 - Elecsys PlGF: 2025-04-15
• 07613336220108 - PreciControl Rubella IgM: 2025-04-15
• 07613336230671 - Elecsys sFlT-1: 2025-04-15
• 07613336230756 - Elecsys PlGF: 2025-04-15
• 07613336223321 - Kidney KFRE Algorithm: 2025-04-08