AESKUSLIDES® ANA-HEp-2

GUDID 04250289500005

AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear and / or cytoplasmic autoantibodies in human serum. The assay is a too

Aesku.Diagnostics GmbH & Co. KG

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

• Primary Device ID: 04250289500005
• NIH Device Record Key: 6da595af-e73f-408f-9462-6be71fe936cc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AESKUSLIDES® ANA-HEp-2
• Version Model Number: 51.100
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250289500005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120889

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-27

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

• 04250289504461: AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear and / or cytopla
• 04250289500005: AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear and / or cytopla