gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz 3002721122

GUDID 04015630916511

Roche Diagnostics GmbH

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

• Primary Device ID: 04015630916511
• NIH Device Record Key: 35f4e530-57a1-4843-8a5f-f22a8323dfdb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz
• Version Model Number: 3002721122
• Catalog Number: 3002721122
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630916511 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972250

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: 2021-01-28
• Device Publish Date: 2021-01-20

On-Brand Devices [gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz]

• 07613336121252: 08057796190
• 04015630926855: 5401461190
• 04015630925018: 5168775190
• 04015630916511: 3002721122