Alegria Flash ENA Screen CL28051

GUDID 00845533003063

The Alegria Flash ENA Screen kit is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to Jo-1, SSA-52, SSA-60, SS-B, Scl-70, Sm, or sm-RNP in human serum. The presence of these autoantibodies is intended for use as an aid in the diagnosis of the connective tissue diseases (CTD) Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), Systemic Sclerosis (SSC).

ZEUS SCIENTIFIC, INC.

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, kit, chemiluminescent immunoassay

• Primary Device ID: 00845533003063
• NIH Device Record Key: 0452e5b7-ceee-47fe-9aea-226c2ba8db04
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alegria Flash ENA Screen
• Version Model Number: CL28051
• Catalog Number: CL28051
• 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
• 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	00845533003063 [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: 2026-02-27
• Device Publish Date: 2026-02-19

Devices Manufactured by ZEUS SCIENTIFIC, INC.

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• 00845533003063 - Alegria Flash ENA Screen: 2026-02-27 The Alegria Flash ENA Screen kit is a chemiluminescent immunoassay (CLIA) for the qualitative screening of IgG autoantibodies to
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