Elecsys Anti-HAV II 08086664190

GUDID 07613336129715

Roche Diagnostics GmbH

Hepatitis A virus immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 07613336129715
• NIH Device Record Key: 4eb6c86b-b75f-4721-91e9-7797c55c1c5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Elecsys Anti-HAV II
• Version Model Number: 08086664190
• Catalog Number: 08086664190
• 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	07613336129715 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190428

FDA Product Code

• LOL: Hepatitis a test (antibody and igm antibody)

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

On-Brand Devices [Elecsys Anti-HAV II]

• 07613336129722: 08086630190
• 07613336129715: 08086664190