AIA-PACK FT3 Calibrator Set

Basic Information

• Brand Name: AIA-PACK FT3 Calibrator Set
• Primary DI: 04560189211193
• Version / Model: N/A
• Company Name: TOSOH CORPORATION
• Labeler DUNS: 690571724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-24
• Public Version: 2
• Public Version Date: 2024-02-14
• Public Version Status: Update
• Public Device Record Key: 41733858-0846-441a-894c-f1902a50641f

Device Characteristics

• Single Use: Yes
• 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: 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
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	862.1710	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38261	Free triiodothyronine (FT3) IVD, calibrator	A material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of free triiodothyronine (FT3) in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14560189211190	GS1		6	In Commercial Distribution
Primary	04560189211193	GS1

Customer Contacts

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

Storage Conditions

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