Identity
- Trade Name
- AESKULISA® ANA-8S EUDAMEDAESKULISA® ANA-8Pro FDA UDI
- Generic Name
- Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AESKULISA® ANA-8S EUDAMEDAESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. FDA UDI
- Model / Reference
- 3100 EUDAMED3101 FDA UDI
- Description
- AESKULISA ANA-8Pro is a solid phase enzyme immunoassay for the separate qualitative detection of IgG antibodies against eight cellular and nuclear antigens in human serum. The wells are separately coated with recombinant 70 kDa U1 snRNP, SS-B, SS-A 52 kDa, Scl 70, centromere protein B (CenpB), Jo-1 and highly purified native human snRNP/Sm, Sm and SS-A 60 kDa. The assay is a tool in the differential diagnosis of systemic rheumatic diseases. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250289500425 EUDAMEDFDA UDI
- Basic UDI-DI
- B-04250289500425 EUDAMED
- 510(k) Number
- K032469 FDA UDI
- FDA Product Code
- LJM FDA UDI
- EMDN Code
- W0102100101 ANA SCREENING EUDAMED
- GMDN Term
- Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class IVD General EUDAMEDClass II FDA UDI
- Regulation Number
- 866.5100 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
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, enzyme immunoassay (EIA)
AESKULISA® ANA-8Pro by Aesku.Diagnostics GmbH & Co. KG — Class II — IVDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA).
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Cleared under the same submission
K032469 also covers:
- AESKULISA® ANA-8Pro — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ENA-6Pro — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® ENA-6Pro — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Jo-1 — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Jo-1 — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® SS-B — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® SS-B — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Scl-70 — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Scl-70 — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Sm — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® Sm — Aesku.Diagnostics GmbH & Co. KG
- AESKULISA® U1-70 — Aesku.Diagnostics GmbH & Co. KG
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Unknown |
| 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 (2)
- FDA UDI da3f645d-0067-41ff-8d0e-dc2ecdc6151d 35 fields · synced Jul 8, 2026
- EUDAMED aff3299e-2115-4cd9-843a-9cd968005630 61 fields · synced Jul 8, 2026