Proinsulin ELISA

Basic Information

• Brand Name: Proinsulin ELISA
• Primary DI: 00404847415605
• Version / Model: EIA-1560
• Catalog Number: EIA-1560
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• Labeler DUNS: 317134468
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-07
• Public Version: 2
• Public Version Date: 2024-01-30
• Public Version Status: Update
• Public Device Record Key: eb5f5547-b82c-4a3d-be74-dc53960229b3
• Distribution End Date: 2024-01-29

Device Description

The DRG Proinsulin ELISA is an enzyme immunoassay for the quantitative in vitro diagnostic measurement of Proinsulin (intact) in serum and plasma.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• 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
54330	Proinsulin IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of proinsulin 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
Primary	00404847415605	GS1

Customer Contacts

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

Storage Conditions

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