MERIFLUOR EBV-NA EN100

GUDID 00840733101953

The MERIFLUOR EBV-NA Test is a rapid, sensitive anti-complement immunofluorescence (ACIF) test for the qualitative or quantitative detection of antibodies to the nuclear antigen of Epstein-Barr virus in human serum. The test can provide valuable diagnostic information to facilitate patient management when used in conjunction with other EBV antibody tests.

MERIDIAN BIOSCIENCE, INC.

Epstein-Barr virus (EBV) antigen IVD, kit, fluorescent immunoassay

• Primary Device ID: 00840733101953
• NIH Device Record Key: bffbb3de-4d96-43fb-b0f0-90218e2c1375
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MERIFLUOR EBV-NA
• Version Model Number: EN100
• Catalog Number: EN100
• 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: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com
• Phone: 1-800-343-3858
• Email: MBI-TechService@meridianbioscience.com

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
• 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	00840733101953 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K880043

FDA Product Code

• LLM: Test, Antigen, Nuclear, Epstein-Barr Virus

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: 2020-11-03
• Device Publish Date: 2020-10-26

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