MONOSPOT Latex 776150

GUDID 00840733101298

MONOSPOT Latex is a one step rapid latex particle agglutination test for the qualitative and semiquantitative determination of infectious mononucleosis heterophile antibodies in serum or plasma.

MERIDIAN BIOSCIENCE, INC.

Epstein-Barr virus (EBV) heterophile antibody IVD, kit, agglutination

• Primary Device ID: 00840733101298
• NIH Device Record Key: 3527f115-3b53-4715-a1b6-6154ebfa72bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MONOSPOT Latex
• Version Model Number: 776150
• Catalog Number: 776150
• Company DUNS: 092815364
• Company Name: MERIDIAN BIOSCIENCE, 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 513-271-3700
• Email: info@meridianbioscience.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840733101298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874678

FDA Product Code

• KTN: System, Test, Infectious Mononucleosis

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: 2016-09-23

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