AESKUSLIDES® nDNA (Crithidia luciliae) 53.120.US

GUDID 04250289513401

AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum.

Aesku.Diagnostics GmbH & Co. KG

Native DNA antibody (anti-nDNA) IVD, kit, fluorescent immunoassay

• Primary Device ID: 04250289513401
• NIH Device Record Key: fec52e59-7dab-40e5-bf95-9b1bd3bdceac
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AESKUSLIDES® nDNA (Crithidia luciliae)
• Version Model Number: 53.120.US
• Catalog Number: 53.120.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
• 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	04250289513401 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172348

FDA Product Code

• LSW: Anti-Dna Antibody, Antigen And 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: 2024-11-25
• Device Publish Date: 2024-11-15

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• 04250289513401 - AESKUSLIDES® nDNA (Crithidia luciliae): 2024-11-25AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a substrate for the qualitative and/or semi-quantitative determination of antibodies to native double stranded DNA (dsDNA) in human serum.
• 04250289513401 - AESKUSLIDES® nDNA (Crithidia luciliae): 2024-11-25 AESKUSLIDES® nDNA (Crithidia luciliae) is an indirect immunofluorescence assay utilizing Crithidia luciliae coated slides as a
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