EL-anti-TPO

Basic Information

• Brand Name: EL-anti-TPO
• Primary DI: 00854473003255
• Version / Model: 104-119
• Catalog Number: 104-119
• Company Name: THERA-TEST LABORATORIES, INC
• Labeler DUNS: 194336954
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-07-28
• Public Version: 4
• Public Version Date: 2024-02-16
• Public Version Status: Update
• Public Device Record Key: efe585d7-baf8-450f-95cf-432c7f07e445

Device Description

ANTI-THYROPEROXIDASE (TPO) ANTIBODY ELISA TEST KIT, 192 TESTS

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
55203	Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to thyroid peroxidase [anti-TPO, also known as anti-microsomal antibody] in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of chronic lymphocytic thyroiditis (also known as hashimoto thyroiditis).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00854473003255	GS1

Premarket Submissions

Submission Number	Supplement Number
K090760	000

Storage Conditions

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