AESKULISA® PR3 sensitive

GUDID 04250289501354

AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocyt

Aesku.Diagnostics GmbH & Co. KG

Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 04250289501354
• NIH Device Record Key: a421d63d-1e22-43b1-880f-86562b4eef64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AESKULISA® PR3 sensitive
• Version Model Number: 3302
• 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	04250289501354 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091859

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: 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® PR3 sensitive]

• 04250289503549: AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native hum
• 04250289501354: AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native hum