ST AIA-PACK C-Peptide II

Basic Information

• Brand Name: ST AIA-PACK C-Peptide II
• Primary DI: 14560189213316
• 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: 9b722063-de35-4c1a-8978-9bdb6609d98f

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
JKD	Radioimmunoassay, C-Peptides Of Proinsulin	Clinical Chemistry	862.1135	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54130	C-peptide IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of C-peptide in a clinical specimen, using a chemiluminescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	24560189213313	GS1		10	In Commercial Distribution
Primary	14560189213316	GS1
Unit of Use	04560189213319	GS1

Customer Contacts

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

Storage Conditions

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