DBC Androstenedione ELISA

Basic Information

• Brand Name: DBC Androstenedione ELISA
• Primary DI: B261CANAD2080
• Version / Model: CAN-AD-208
• Catalog Number: CAN-AD-208
• Company Name: Diagnostics Biochem Canada Inc
• Labeler DUNS: 207718438
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-11-15
• Public Version: 1
• Public Version Date: 2022-11-23
• Public Version Status: New
• Public Device Record Key: 5b745aa8-7a41-42c3-bf3b-67d0bc9de02e

Device Description

For the quantitative measurement of Androstenedione in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.

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: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CIZ	Radioimmunoassay, Androstenedione	Clinical Chemistry	862.1075	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54069	Androstenedione IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative measurement of androstenedione 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	B261CANAD2080	HIBCC

Customer Contacts

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

Storage Conditions

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