Access DHEA-S

Basic Information

• Brand Name: Access DHEA-S
• Primary DI: 15099590201432
• Version / Model: A10826
• Catalog Number: A10826
• Company Name: Beckman Coulter, Inc.
• Labeler DUNS: 008254708
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-09-23
• Public Version: 1
• Public Version Date: 2021-10-01
• Public Version Status: New
• Public Device Record Key: 3735a973-688c-4cab-922a-a9f3dd412684

Device Description

The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.

Device Characteristics

• Single Use: No
• 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
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	862.1245	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
Primary	15099590201432	GS1