MONOLISA 72495

GUDID 00847865012379

MONOLISA Anti-HAV IgM EIA

BIO-RAD

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

• Primary Device ID: 00847865012379
• NIH Device Record Key: 3b6ae32e-88f0-40b7-b508-b9f1629e3fee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONOLISA
• Version Model Number: 72495
• Catalog Number: 72495
• Company DUNS: 269902602
• Company Name: BIO-RAD
• 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: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-800-224-6723
• Email: techsupport.ussd-redmond@bio-rad.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847865012379 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092353

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-12

On-Brand Devices [MONOLISA]

• 00847865012379: MONOLISA Anti-HAV IgM EIA
• 00847865012362: MONOLISA Anti-HAV EIA