ST AIA-PACK E2

Basic Information

• Brand Name: ST AIA-PACK E2
• Primary DI: 14560189210384
• Version / Model: N/A
• Company Name: TOSOH CORPORATION
• Labeler DUNS: 690571724
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• 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: 462ca108-c4bf-42cc-be52-6af83d35b219

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
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	862.1260	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54152	Estradiol (oestradiol) (E2) IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24560189210381	GS1		10	In Commercial Distribution
Primary	14560189210384	GS1
Unit of Use	04560189210387	GS1

Customer Contacts

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

Storage Conditions

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