AESKUSLIDES® ANA-HEp-2 gamma 51.181.US

GUDID 04250289513487

AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum.

Aesku.Diagnostics GmbH & Co. KG

Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay

• Primary Device ID: 04250289513487
• NIH Device Record Key: 93246fcd-bd42-4269-8039-87ebba279476
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AESKUSLIDES® ANA-HEp-2 gamma
• Version Model Number: 51.181.US
• Catalog Number: 51.181.US
• Company DUNS: 341714388
• Company Name: Aesku.Diagnostics GmbH & Co. KG
• 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

• Special Storage Condition, Specify: Between 0 and 0 *2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C
• Special Storage Condition, Specify: Between 0 and 0 *2-8°C

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250289513487 [Primary]

FDA Product Code

• DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

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: 2025-04-14
• Device Publish Date: 2025-04-06

On-Brand Devices [AESKUSLIDES® ANA-HEp-2 gamma ]

• 04250289504935: AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coa
• 04250289513562: AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coa
• 04250289513487: AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coa