ANA Screen ELISA Test Kit 4884261

GUDID 00840733101014

The Antinuclear Antibody Screening Test is a qualitative enzyme immunassay (EIA) intended to screen for the presence of antinuclear antibodies (ANAs) in human serum as an aid in the diagnosis of certain systemic rheumatic diseases. This assay collectively detects, in one well, total ANAs against double stranded DNA (dsDNA, nDNA) histones, SS-A/Ro, SS-B/La, Sm, SmRNP, Sci-70, Jo-1, and centrometric antigens, along with sera postive for immunoflourescent (IFA) HEp-2 ANAs.

MERIDIAN BIOSCIENCE, INC.

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00840733101014
• NIH Device Record Key: 589e42db-f66e-429f-82f8-ec5137e07f23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ANA Screen ELISA Test Kit
• Version Model Number: 4884261
• Catalog Number: 4884261
• 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	00840733101014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954723

FDA Product Code

• LKJ: Antinuclear Antibody, Antigen, Control

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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