Identity
- Trade Name
- AESKUSLIDES® ANA-HEp-2 gamma FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay FDA UDI
- Device Name
- AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. FDA UDI
- Model / Reference
- 51.101.US FDA UDI
- Description
- AESKUSLIDES® ANA HEp-2-Gamma is an indirect fluorescent antibody assay utilizing HEp-2 cell coated slides as a substrate for the qualitative and/or semi-quantitative determination of antinuclear antibodies (ANA) in human serum. FDA UDI
Identifiers
- Catalog Number
- 51.101.US FDA UDI
- Primary DI / UDI-DI
- 04250289504935 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
- 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 antinuclear antibody (ANA) screening IVD, kit, fluorescent immunoassay
AESKUSLIDES® ANA-HEp-2 gamma 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
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 68b6b153-ddc6-4cef-b0d5-2e34083ae028 35 fields · synced May 29, 2026