Islet Cell Antibodies (Primate Pancreas)

Basic Information

• Brand Name: Islet Cell Antibodies (Primate Pancreas)
• Primary DI: 00845533002448
• Version / Model: 5548L
• Catalog Number: 5548L
• Company Name: ZEUS SCIENTIFIC, INC.
• Labeler DUNS: 080953946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-16
• Public Version: 1
• Public Version Date: 2025-12-24
• Public Version Status: New
• Public Device Record Key: 67f76d6d-b7e9-42b3-a925-4915bfe98a22

Device Description

Indirect Immunofluorescence assay for the detection of Islet Cell antibodies in human serum on primate pancreas sections. Islet Cell antibodies have been associated with a group of "Autoimmune" endocrine disorders, more specifically with insulin dependent diabetes.

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
54991	Islet cell 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 one or multiple islet cell antigens 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	00845533002448	GS1

Storage Conditions

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