Identity
- Trade Name
- AESKULISA® Sm FDA UDI
- Generic Name
- Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the quantitative and qualitative detection of antibodies against Sm in human serum. Anti-Sm antibodies recognize specific conformational epitopes only accessible on native human Sm. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE). FDA UDI
- Model / Reference
- 7106US FDA UDI
- Description
- AESKULISA Sm is a solid phase enzyme immunoassay with highly purified native Smith antigen (Sm) from human eukaryotic cells (HeLa) for the quantitative and qualitative detection of antibodies against Sm in human serum. Anti-Sm antibodies recognize specific conformational epitopes only accessible on native human Sm. The assay is a tool in the differential diagnosis of systemic lupus erythematosus (SLE). FDA UDI
Identifiers
- Catalog Number
- 7106US FDA UDI
- Primary DI / UDI-DI
- 04250289502962 FDA UDI
- 510(k) Number
- K032469 FDA UDI
- FDA Product Code
- LJM FDA UDI
- GMDN Term
- Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) 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: Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA)
AESKULISA® Sm by Aesku.Diagnostics GmbH & Co. KG — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA).
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- EL-ANA PROFILES: ANA/4 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/4 — THERATEST LABORATORIES, INC.
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ELISA Sm/RNP Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- Gold Standard Diagnostics Is-anti-Sm/RNP ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- SeraQuest — QUEST INTERNATIONAL, INC. · Class II
- ELISA Sm/RNP Test System — ZEUS SCIENTIFIC, INC.
Cleared under the same submission
K032469 also covers:
- AESKULISA® ANA-8Pro — Aesku.Diagnostics GmbH & Co. KG
- 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® U1-70 — Aesku.Diagnostics GmbH & Co. KG
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Aesku.Diagnostics GmbH & Co. KG
Sources (1)
- FDA UDI 54955daa-fa90-4008-a797-a92741ae5dbc 36 fields · synced May 31, 2026