AESKUSLIDES® ANA HEp-2-Gamma 51.101.US.Bulk5

GUDID 04250289504942

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 by manual microscopy or with the HELIOS® Automated IFA System. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.

Aesku.Diagnostics GmbH & Co. KG

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

• Primary Device ID: 04250289504942
• NIH Device Record Key: b3a9dc3d-41d1-471e-a9fa-14bd3d5e1979
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AESKUSLIDES® ANA HEp-2-Gamma
• Version Model Number: 51.101.US.Bulk5
• Catalog Number: 51.101.US.Bulk5
• 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	04250289504942 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153117

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2026-02-09
• Device Publish Date: 2025-05-27

Devices Manufactured by Aesku.Diagnostics GmbH & Co. KG

• 04250289504942 - AESKUSLIDES® ANA HEp-2-Gamma: 2026-02-09AESKUSLIDES® 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 by manual microscopy or with the HELIOS® Automated IFA System. This in vitro diagnostic assay is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other clinical and laboratory findings.
• 04250289504942 - AESKUSLIDES® ANA HEp-2-Gamma: 2026-02-09 AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for t
• 04250289513487 - AESKUSLIDES® ANA-HEp-2 gamma: 2025-04-14 AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for th
• 04250289513562 - AESKUSLIDES® ANA-HEp-2 gamma: 2025-04-14 AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for th
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• 04250289512909 - HERA: 2023-07-28
• 04250289512541 - HELIOS® AUTOMATED IFA SYSTEM: 2023-07-03