Thyretain

Basic Information

• Brand Name: Thyretain
• Primary DI: 30014613338383
• Version / Model: 40-100100
• Catalog Number: 40-100100
• Company Name: DIAGNOSTIC HYBRIDS, INC.
• Labeler DUNS: 117359612
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-07
• Public Version: 1
• Public Version Date: 2019-03-15
• Public Version Status: New
• Public Device Record Key: 866f074c-4894-4f3a-bfc8-021040e0cb49

Device Description

GROWTH MEDIUM

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: 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
54393	Thyroid stimulating hormone receptor (TSHR) 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 thyroid stimulating hormone receptor (TSHR), also known as thyrotropin receptor, in a clinical specimen using a chemiluminescent immunoassay method. It is used in the diagnosis of autoimmune thyroid disorders such as hyperthyroidism in Graves’ disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	30014613338383	GS1

Customer Contacts

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