IMMULITE® Systems TG Recovery Sample Thyroglobulin

Basic Information

• Brand Name: IMMULITE® Systems TG Recovery Sample Thyroglobulin
• Primary DI: 00630414954523
• Version / Model: 10381639
• Catalog Number: LTYRM
• 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: 2023-01-12
• Public Version Status: Update
• Public Device Record Key: 245f76f9-7ce6-4478-8cfc-ed252acf4cd4

Device Description

Thyreoglobulin Recovery Sample - IMMULITE - CONS - 80 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
MSW	System,test,thyroglobulin	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54376	Thyroglobulin IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of thyroglobulin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00630414954523	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K982466	000

Storage Conditions

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