DHEA-S

Basic Information

• Brand Name: DHEA-S
• Primary DI: 04048474046526
• Version / Model: CLA4652
• Catalog Number: CLA-4652
• Company Name: DRG Instruments Gesellschaft mit beschränkter Haftung
• Labeler DUNS: 317134468
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-26
• Public Version: 1
• Public Version Date: 2023-09-04
• Public Version Status: New
• Public Device Record Key: 8e3687fa-a09e-4dca-9983-934812605798

Device Description

For the direct quantitative determination of DHEAS by an enzyme immunoassay in human serum.

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
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	862.1245	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54136	Dehydroepiandrosterone (DHEA) IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of dehydroepiandrosterone (DHEA) in a clinical specimen, using a radioimmunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04048474046526	GS1

Customer Contacts

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

Storage Conditions

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