PreciControl Anti-HAV II 08086672190

GUDID 07613336129746

Roche Diagnostics GmbH

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, control

• Primary Device ID: 07613336129746
• NIH Device Record Key: ddbd1f3b-98e9-4b9b-876e-c359ae1513b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreciControl Anti-HAV II
• Version Model Number: 08086672190
• Catalog Number: 08086672190
• 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	07613336129746 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190428

FDA Product Code

• QCH: Assayed quality control material for clinical microbiology assays

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: 2019-10-08
• Device Publish Date: 2019-09-30

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• 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