Total Triiodothyronine (tT3) ELISA

Basic Information

• Brand Name: Total Triiodothyronine (tT3) ELISA
• Primary DI: 04048474052664
• Version / Model: EIA-5266
• Catalog Number: EIA-5266
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• Labeler DUNS: 317134468
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-09-01
• Public Version: 2
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: a225b755-5f94-49ab-80d6-64fc583e8c8f

Device Description

The measurement of the total amount of binding sites available for the Thyroid Hormones in human serum or plasma by a microplate enzyme Immunoassay.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: Yes
• 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
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	862.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54395	Multiple thyroid hormone uptake (T-uptake) IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the unbound/free portion of multiple proteins [e.g., thyroxine binding globulin (TBG), transthyretin and/or albumin] associated with thyroid hormone uptake, using a radioimmunoassay method. It is typically used to aid in the assessment of thyroid hormone binding capacity for the diagnosis of thyroid disorders associated with hypothyroidism or hyperthyroidism.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048474052664	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K971780	000

Storage Conditions

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