Identity
- Trade Name
- EL-ANA Profiles: anti-RNP/Sm FDA UDI
- Generic Name
- Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- ANTI-RNP/SM ANTIBODY ELISA TEST KIT, 96 TESTS FDA UDI
- Model / Reference
- 104-601 FDA UDI
- Description
- ANTI-RNP/SM ANTIBODY ELISA TEST KIT, 96 TESTS FDA UDI
Identifiers
- Catalog Number
- 104-601 FDA UDI
- Primary DI / UDI-DI
- 00854473003118 FDA UDI
- 510(k) Number
- K051066 FDA UDI
- GMDN Term
- Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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)
EL-ANA Profiles: anti-RNP/Sm by Theratest Laboratories, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA).
- AESKULISA® Sm — Aesku.Diagnostics GmbH & Co. KG · Class II
- Autoimmune EIA — Bio-Rad Laboratories · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ELISA Sm/RNP Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- AESKULISA® Sm — Aesku.Diagnostics GmbH & Co. KG · Class II
- 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
K051066 also covers:
- EL-ANA PROFILES: ANA/4 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/4 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/6 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/7 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/8 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/9 — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-HISTONE — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-SSA — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-Scl-70 — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-Sm — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-dsDNA — THERATEST LABORATORIES, INC.
- EL-ANA Profiles: anti-ssDNA — THERATEST LABORATORIES, INC.
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Theratest Laboratories, Inc.
Sources (1)
- FDA UDI 559fc24b-0bc1-426e-a14e-23bac7dbb565 36 fields · synced Jun 8, 2026