AESKULISA® ANA-HEp-2 30-7115US

GUDID 04250289503501

AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection of IgG antibodies against HEp2 cells in human serum. Ea

Aesku.Diagnostics GmbH & Co. KG

Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04250289503501
• NIH Device Record Key: 4e13136a-5aa2-4165-ba27-2d265c432fee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AESKULISA® ANA-HEp-2
• Version Model Number: 30-7115US
• Catalog Number: 30-7115US
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04250289503501 [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: 2017-02-28

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

• 04250289503501: AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection o
• 04250289503020: AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection o
• 04250289500579: AESKULISA ANA-HEp-2 is a solid phase enzyme immunoassay for the combined qualitative detection o