Identity
- Trade Name
- ELISA Sm/RNP Smart Kit Test System FDA UDI
- Generic Name
- Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Sm/RNP Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm/RNP in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- SM2Z2841G FDA UDI
- Description
- The ZEUS ELISA Sm/RNP Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm/RNP in human sera. When performed according to these instructions, the results of this assay may aid in the diagnosis and treatment of autoimmune connective tissue disorders. This device is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- SM2Z2841G FDA UDI
- Primary DI / UDI-DI
- 00845533001106 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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)
ELISA Sm/RNP Smart Kit Test System by Zeus Scientific, 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
- EL-ANA PROFILES: ANA/4 — THERATEST LABORATORIES, INC.
- EL-ANA PROFILES: ANA/4 — THERATEST LABORATORIES, INC.
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- 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
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
- Zeus Scientific, Inc.
Sources (1)
- FDA UDI dfca848a-5566-4bd7-be33-b25d3a8bab6a 35 fields · synced May 30, 2026