Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2)

Basic Information

• Brand Name: Atellica CH Gamma-Glutamyl Transferse 2 (GGT_2)
• Primary DI: 00630414628707
• Version / Model: 11537248
• Catalog Number: 11537248
• Company Name: Siemens Healthcare Diagnostics Inc.
• Labeler DUNS: 064608573
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 4
• Record Status: Published
• Publish Date: 2024-02-02
• Public Version: 1
• Public Version Date: 2024-02-12
• Public Version Status: New
• Public Device Record Key: 5442dd9c-69a6-4068-bc77-4fb298f85fa0

Device Description

Gamma-Glutamyl Transferase (GGT_2) Reagents

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• 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: Yes
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JQB	KINETIC METHOD, GAMMA-GLUTAMYL TRANSPEPTIDASE	Clinical Chemistry	862.1360	1

GMDN Terms

Code	Name	Definition	Implantable	Status
53027	Gamma-glutamyltransferase (GGT) IVD, kit, spectrophotometry	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of gamma glutamyltransferase (GGT) in a clinical specimen, using a spectrophotometry method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00630414313382	GS1
Primary	00630414628707	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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