ZEUS IFA ANA HEp-2 Test System FA2500A

GUDID 00845533001809

The ZEUS IFA ANA HEp-2 Test System is a pre-standardized assay designed for the qualitative and semi-quantitative detection of antinuclear antibodies. The test is intended to aid in determining SLE and differentiating clinically similar connective tissue disorders, and is for In Vitro diagnostic use.

ZEUS SCIENTIFIC, INC.

Multiple systemic lupus erythematosus (SLE)-associated antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00845533001809
• NIH Device Record Key: 8f9b732a-187f-4a09-a4b4-d8a1d3e691c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZEUS IFA ANA HEp-2 Test System
• Version Model Number: FA2500A
• Catalog Number: FA2500A
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533001809 [Primary]

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: 2019-01-03
• Device Publish Date: 2018-12-03

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