IMMULITE® 2000 Systems ATG Anti-TG Ab (Anti-Thyroglobulin Ab)

Basic Information

• Brand Name: IMMULITE® 2000 Systems ATG Anti-TG Ab (Anti-Thyroglobulin Ab)
• Primary DI: 00630414962115
• Version / Model: 10381655
• Catalog Number: L2KTG6
• 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: 2016-09-24
• Public Version: 6
• Public Version Date: 2023-05-19
• Public Version Status: Update
• Public Device Record Key: 65237b47-6777-46a7-8308-4ec2955dd960

Device Description

TG Ab - IMMULITE - RGT - 600 Tests

Device Characteristics

• Single Use: Yes
• 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	00630414962115	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K991094	000

Storage Conditions

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