AESKUSLIDES ANCA Formalin

GUDID 04250289510363

AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyte coated slides, fixed with Ethanol or Formalin, as a s

Aesku.Diagnostics GmbH & Co. KG

Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay

• Primary Device ID: 04250289510363
• NIH Device Record Key: 97973882-9201-402f-b975-360f9fe75418
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AESKUSLIDES ANCA Formalin
• Version Model Number: 54.101.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: false
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250289510363 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172461

FDA Product Code

• MOB: Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-05-25

On-Brand Devices [AESKUSLIDES ANCA Formalin]

• 04250289510387: AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyt
• 04250289510363: AESKUSLIDES® ANCA is an indirect immunofluorescence assay utilizing human neutrophil granulocyt