Alegria Flash ENA Screen Control Kit

Basic Information

• Brand Name: Alegria Flash ENA Screen Control Kit
• Primary DI: 00845533003070
• Version / Model: CL28051CK
• Catalog Number: CL28051CK
• Company Name: ZEUS SCIENTIFIC, INC.
• Labeler DUNS: 080953946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-19
• Public Version: 1
• Public Version Date: 2026-02-27
• Public Version Status: New
• Public Device Record Key: 810d3cfe-e303-4609-9572-6362b844b3f8

Device Description

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
46080	Multiple extractable nuclear antigen antibody (anti-ENA) screening IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative screening for multiple types of antibodies to extractable nuclear antigens (anti-ENA) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845533003070	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius