AESKULISA® Sm

GUDID 04250289500487

AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the quantitativ

Aesku.Diagnostics GmbH & Co. KG

Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04250289500487
• NIH Device Record Key: ea36d804-b22e-484a-9bc8-c509a893cd62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AESKULISA® Sm
• Version Model Number: 3106
• 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	04250289500487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K032469

FDA Product Code

• LJM: Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls

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 [AESKULISA® Sm ]

• 04250289502962: AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm)
• 04250289500487: AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm)