Identity
- Trade Name
- AESKULISA® PR3 sensitive FDA UDI
- Generic Name
- Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the quantitative and qualitative detection of antibodies against proteinase 3 in human serum. Anti-PR3 antibodies recognize specificially conformational epitopes only accessible on native PR3. The assay is an aid in the differential diagnosis of autoimmune vasculitis. 30'+30'+30' automation incubation. FDA UDI
- Model / Reference
- 30-7302US FDA UDI
- Description
- AESKULISA PR3 sensitive is a solid phase enzyme immunoassay employing highly purified native human proteinase 3 (PR3) from human neutrophil granulocytes for the quantitative and qualitative detection of antibodies against proteinase 3 in human serum. Anti-PR3 antibodies recognize specificially conformational epitopes only accessible on native PR3. The assay is an aid in the differential diagnosis of autoimmune vasculitis. 30'+30'+30' automation incubation. FDA UDI
Identifiers
- Catalog Number
- 30-7302US FDA UDI
- Primary DI / UDI-DI
- 04250289503549 FDA UDI
- 510(k) Number
- K091859 FDA UDI
- FDA Product Code
- MOB FDA UDI
- GMDN Term
- Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Multiple vasculitis-associated antibody IVD, kit, enzyme immunoassay (EIA)
AESKULISA® PR3 sensitive by Aesku.Diagnostics GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K091859 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Aesku.Diagnostics GmbH & Co. KG
Sources (1)
- FDA UDI 76276594-8a95-4dcf-900c-16dda7f74f0b 36 fields · synced Jun 1, 2026