GGT Assay SK334-20

GUDID 00628063401093

SEKISUI DIAGNOSTICS, LLC

Gamma-glutamyltransferase (GGT) IVD, kit, enzyme spectrophotometry

• Primary Device ID: 00628063401093
• NIH Device Record Key: a4630bb5-533b-4e9a-874a-bf04c88a6ed6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GGT Assay
• Version Model Number: SK334-20
• Catalog Number: SK334-20
• Company DUNS: 966812344
• Company Name: SEKISUI DIAGNOSTICS, LLC
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628063401093 [Primary]

FDA Product Code

• JQB: KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE

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: 2018-10-25
• Device Publish Date: 2018-09-24

On-Brand Devices [GGT Assay]

• 00628063401093: SK334-20
• 00628063400508: 334-10