Alegria Flash ENA Screen Control Kit CL28051CK

GUDID 00845533003070

The Alegria Flash ENA Screen Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monitor the performance of the Alegria Flash ENA Screen kit. The performance characteristics of the Alegria Flash ENA Screen Control Kit have not been established for any other assays or instrument platforms.

ZEUS SCIENTIFIC, INC.

Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control

• Primary Device ID: 00845533003070
• NIH Device Record Key: 810d3cfe-e303-4609-9572-6362b844b3f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alegria Flash ENA Screen Control Kit
• Version Model Number: CL28051CK
• Catalog Number: CL28051CK
• 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	00845533003070 [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

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• 00845533003070 - Alegria Flash ENA Screen Control Kit: 2026-02-27 The Alegria Flash ENA Screen Control Kit (Positive and Negative) is intended for use as assayed quality control samples to monit
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