P. THR PACK 4 WELL

Basic Information

• Brand Name: P. THR PACK 4 WELL
• Primary DI: 00813545020439
• Version / Model: 5001
• Catalog Number: 5001
• Company Name: SCIMEDX CORPORATION
• Labeler DUNS: 155424708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-14
• Public Version: 5
• Public Version Date: 2023-10-18
• Public Version Status: Update
• Public Device Record Key: 432f56e8-b274-4547-9dd6-ebc8f199ad57

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: Yes
• 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
55208	Multiple thyroid antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of multiple antibodies to the thyroid gland and/or specific products of thyroid gland metabolism in a clinical specimen, using a fluorescent immunoassay method. This test detects autoantibodies directed at antigens such as thyroid gland tissue, thyroglobulin, and thyroid peroxidase (TPO) [known as anti-microsomal antibody] to aid in the diagnosis of autoimmune thyroid diseases such as autoimmune thyroiditis (Hashimoto’s disease) and Graves’ disease.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00813545020439	GS1

Customer Contacts

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