MONOLISA™ 26200

GUDID 00847865013147

Anti-HBc IgM EIA, Positive Control,1.6 mL

Bio-RAD Laboratories, Inc.

Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control Hepatitis B virus core immunoglobulin M (IgM) antibody IVD, control

• Primary Device ID: 00847865013147
• NIH Device Record Key: 9644f1cb-ed0f-4223-abde-77d2c6c212ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONOLISA™
• Version Model Number: 26200
• Catalog Number: 26200
• 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: 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: 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

Device Dimensions

• Total Volume: 1.6 Milliliter
• Total Volume: 1.6 Milliliter
• Total Volume: 1.6 Milliliter
• Total Volume: 1.6 Milliliter
• Total Volume: 1.6 Milliliter
• Total Volume: 1.6 Milliliter
• Total Volume: 1.6 Milliliter
• Total Volume: 1.6 Milliliter

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00847865013147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P060034

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: 6
• Public Version Date: 2020-01-23
• Device Publish Date: 2014-08-22

On-Brand Devices [MONOLISA™]

• 00847865013178: Anti-HBc IgM EIA, Cutoff Calibrator, 1.5 mL
• 00847865013161: Anti-HBc IgM EIA, Conjugate, Lyophilized, 7.5 mL
• 00847865013154: Anti-HBc IgM EIA, Negative Control, 0.8 mL
• 00847865013147: Anti-HBc IgM EIA, Positive Control,1.6 mL
• 00847865013130: Anti-HBc IgM EIA, Specimen Diluent, 30 mL
• 00847865013123: Anti-HBc IgM EIA Conjugate Diluent, 30 mL
• 00847865013116: Anti-HBc EIA, Negative Control, 0.8 mL
• 00847865013109: Anti-HBc EIA, Specimen Diluent, 30 mL
• 00847865013093: Anti-HBc EIA, Cutoff Calibrator, 1.5 mL
• 00847865013086: Anti-HBc EIA, Positive Control, 0.8 mL
• 00847865013079: Anti-HBc EIA, Conjugate Reagent 30 mL
• 00847865011372: MONOLISA™ Anti-HBc EIA 192 Tests
• 00847865011365: MONOLISA™ Anti-HBc IgM EIA, 192 Tests
• 00847865002110: Anti-HBs EIA, Specimen Diluent 10 mL
• 00847865002103: Anti-HBs EIA, Conjugate Diluent 15 mL
• 00847865002097: Anti-HBs EIA, 10 mIU/mL Calibrator 1.8 mL
• 00847865002080: Anti-HBs EIA, Negative Control 1.5 mL
• 00847865002073: Anti-HBs EIA, Positive Control 1.5 mL
• 00847865002066: Anti-HBs EIA Hepatitis B Surface Antigen (Human) Horeseradish Peroxidase Conjugate
• 00847865002042: MONOLISA™ Anti-HBs EIA Calibrator Kit