Identity
- Trade Name
- AESKUSLIDES® ANA-HEp-2 FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear and / or cytoplasmic autoantibodies in human serum. The assay is a tool in the differential diagnosis of systemic rheumatic diseases like systemic lupus erythematosus (SLE), mixed connective tissue diseases (MCTD), scleroderma, Sjögren’s syndrome (SS), polymyositis and dermatomyositis. FDA UDI
- Model / Reference
- 51.100 FDA UDI
- Description
- AESKUSLIDES ANA-HEp-2 is an indirect immunofluorescence assay to detect nuclear and / or cytoplasmic autoantibodies in human serum. The assay is a tool in the differential diagnosis of systemic rheumatic diseases like systemic lupus erythematosus (SLE), mixed connective tissue diseases (MCTD), scleroderma, Sjögren’s syndrome (SS), polymyositis and dermatomyositis. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250289500005 FDA UDI
- 510(k) Number
- K120889 FDA UDI
- FDA Product Code
- DHN FDA UDI
- GMDN Term
- Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- Commercial Distribution
- Not 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
AESKUSLIDES® ANA-HEp-2 by Aesku.Diagnostics GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K120889 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 6da595af-e73f-408f-9462-6be71fe936cc 35 fields · synced May 30, 2026