Boditech TSH Control

Basic Information

• Brand Name: Boditech TSH Control
• Primary DI: 08806133060353
• Version / Model: AFIAS-TSHCLT
• Company Name: Boditech Med Inc.
• Labeler DUNS: 689062203
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-10-17
• Public Version: 1
• Public Version Date: 2018-11-19
• Public Version Status: New
• Public Device Record Key: 11eb2b31-6e71-4750-937b-91ae69eeecae

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
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	862.1690	2
KHO	Fluorometer, For Clinical Use	Clinical Chemistry	862.2560	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54387	Thyroid stimulating hormone (TSH) IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of thyroid stimulating hormone (TSH) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08806133060353	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K170232	000