ELISA H. pylori IgG Bulk Test System 3Z51021GB

GUDID 00845533000635

The ZEUS ELISA Helicobacter pylori IgG Test System is an enzyme-linked immunosorbent assay for the qualitative detection of IgG antibodies to H. pylori in sera from symptomatic adults. This device is for In Vitro diagnostic use.

ZEUS SCIENTIFIC, INC.

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 00845533000635
• NIH Device Record Key: c1158253-2762-4afe-81f1-3d43bb478a6b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELISA H. pylori IgG Bulk Test System
• Version Model Number: 3Z51021GB
• Catalog Number: 3Z51021GB
• 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	00845533000635 [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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