MONOLISA 25220

GUDID 00847865002059

MONOLISA™ Anti-HBs EIA 192 tests

Bio-RAD Laboratories, Inc.

Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA) Hepatitis B virus surface total antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00847865002059
• NIH Device Record Key: 49eb71a0-5ae1-49fa-bc81-182d04ab3b3a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONOLISA
• Version Model Number: 25220
• Catalog Number: 25220
• Company DUNS: 844766394
• Company Name: Bio-RAD Laboratories, Inc.
• 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
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com
• Phone: +1(800)224-6723
• Email: techsupport.ussd-redmond@bio-rad.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847865002059 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P050048

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: 5
• Public Version Date: 2020-01-23
• Device Publish Date: 2014-08-22

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