Accutest TSH Test

Basic Information

• Brand Name: Accutest TSH Test
• Primary DI: 10763924801258
• Version / Model: MD801
• Company Name: JANT PHARMACAL CORPORATION
• Labeler DUNS: 797393659
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 4
• Public Version Date: 2018-09-24
• Public Version Status: Update
• Public Device Record Key: 11ed2f9b-1c57-4529-94ca-930990c8c786

Device Description

TSH Test - Thyroid Stimulating Hormone testing device.

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
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	862.1690	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54392	Thyroid stimulating hormone receptor (TSHR) antibody IVD, kit, radioimmunoassay	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 radioimmunoassay 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	10763924801258	GS1
Unit of Use	00763924801251	GS1

Premarket Submissions

Submission Number	Supplement Number
K990658	000