Adrenal Cortex (Primate) 6448L

GUDID 00845533002899

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.

ZEUS SCIENTIFIC, INC.

Adrenal antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00845533002899
• NIH Device Record Key: 0e972b82-3e0d-4295-8f7f-9795856f98b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Adrenal Cortex (Primate)
• Version Model Number: 6448L
• Catalog Number: 6448L
• Company DUNS: 080953946
• Company Name: ZEUS SCIENTIFIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Handling Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533002899 [Primary]

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-26
• Device Publish Date: 2026-02-18

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