ELISA Gliadin IgA Test System 2Z61001A

GUDID 00845533000581

The ZEUS ELISA Gliadin IgA Test System is intended for the qualitative and semi-quantitative detection of IgA-class antibodies to gliadin in human serum. This test is intended to be used as an aid in the diagnosis of gastrointestinal disorders, mainly Celiac Disease. This test is for In Vitro diagnostic use.

ZEUS SCIENTIFIC, INC.

Multiple Coeliac disease-associated antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533000581
• NIH Device Record Key: 86cb7d95-aad2-4376-9be2-ee98e3278253
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELISA Gliadin IgA Test System
• Version Model Number: 2Z61001A
• Catalog Number: 2Z61001A
• 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	00845533000581 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

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