Atellica IM Anti-Thyroglobulin II (aTgII)

Basic Information

• Brand Name: Atellica IM Anti-Thyroglobulin II (aTgII)
• Primary DI: 00630414245317
• Version / Model: 11201759
• Catalog Number: 11201759
• Company Name: SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
• Labeler DUNS: 296822794
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-04
• Public Version: 1
• Public Version Date: 2026-02-12
• Public Version Status: New
• Public Device Record Key: 107644da-f755-4303-a60d-93b7b96b4a9d

Device Description

Atellica IM Anti-Thyroglobulin II (aTgII) - 100T

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: No
• 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
JZO	SYSTEM, TEST, THYROID AUTOANTIBODY	Immunology	866.5870	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58728	Thyroglobulin antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroglobulin in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414245317	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K250816	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Upright
• Type: Handling Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius