Adrenal Cortex (Primate)

Basic Information

• Brand Name: Adrenal Cortex (Primate)
• Primary DI: 00845533002899
• Version / Model: 6448L
• Catalog Number: 6448L
• Company Name: ZEUS SCIENTIFIC, INC.
• Labeler DUNS: 080953946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-18
• Public Version: 1
• Public Version Date: 2026-02-26
• Public Version Status: New
• Public Device Record Key: 0e972b82-3e0d-4295-8f7f-9795856f98b0

Device Description

Adrenal antibodies are associated with the idiopathic form of Addison's Disease, and are more common in males than females. Early detection of auto-antibodies in patient with sub-clinical Adrenal deficiency who developed an adrenal crisis during infection or appendicitis, can be life saving. Cases have been noted where young patients with unsuspected Addison's disease have died before a diagnosis had been reached. Many patients with adrenal antibodies also have an overlap of additional diseases such as thyroid disease, insulin-dependent diabetes, and secondary amenorrhea. Screening for adrenal antibodies in these circumstances could be very beneficial as very low incidence of adrenal antibody are found in normal.

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: No
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
54862	Adrenal antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to the adrenal gland in a clinical specimen, using a fluorescent immunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00845533002899	GS1

Storage Conditions

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