Islet Cell Antibodies (Primate Pancreas) 5548L

GUDID 00845533002448

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.

ZEUS SCIENTIFIC, INC.

Islet cell antibody IVD, kit, fluorescent immunoassay

• Primary Device ID: 00845533002448
• NIH Device Record Key: 67f76d6d-b7e9-42b3-a925-4915bfe98a22
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Islet Cell Antibodies (Primate Pancreas)
• Version Model Number: 5548L
• Catalog Number: 5548L
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00845533002448 [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: 2025-12-24
• Device Publish Date: 2025-12-16

Devices Manufactured by ZEUS SCIENTIFIC, INC.

• 00845533002721 - Anti-EBV VCA IgM: 2026-01-23 The Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM is an enzyme-linked immunosorbent assay (ELISA) designed for the quali
• 00845533002738 - Anti-EBV VCA IgM: 2026-01-23 The ELISA Epstein-Barr Virus Viral Capsid Antigen (EBV-VCA) IgM is an enzyme-linked immunosorbent assay (ELISA) designed for the
• 00845533002745 - Anti-PR3: 2026-01-23 The Anti Proteinase-3 (PR-3) is intended for the qualitative and semi-quantitative detection of IgG-class antibody to proteninas
• 00845533002752 - Anti-PR3: 2026-01-23 The Anti Proteinase-3 (PR-3) Test System is intended for the qualitative and semi-quantitative detection of IgG-class antibody t
• 00845533002769 - Anti-Sm: 2026-01-23 The Anti Sm Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm in human sera. When perform
• 00845533002776 - Anti-Sm: 2026-01-23 The Anti Sm Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm in human sera. When perform
• 00845533002783 - Anti-SSA (Ro): 2026-01-23 The Anti SSA (Ro) is a semi-quantitative immunoassay for the detection of IgG antibodies to SSA in human sera. When performed ac
• 00845533002790 - Anti-SSA (Ro): 2026-01-23 The Anti SSA (Ro) is a semi-quantitative immunoassay for the detection of IgG antibodies to SSA in human sera. When performed ac