AIA-PACK IRI CALIBRATOR SET

Basic Information

• Brand Name: AIA-PACK IRI CALIBRATOR SET
• Primary DI: 04560189211407
• 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: 7bad4238-ca3c-4547-91e9-1e0d298356e8

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
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	862.1405	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54819	Multiple diabetes mellitus-associated antibody IVD, calibrator	A material which is used to establish known points of reference for a number of assays intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with diabetes mellitus in a clinical specimen. These antibodies may include autoimmune antibodies directed at insulin, islet cells and/or glutamic acid decarboxylase (anti-GAD).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	14560189211404	GS1		6	In Commercial Distribution
Primary	04560189211407	GS1

Customer Contacts

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

Storage Conditions

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