Identity
- Trade Name
- ELISA Sm Test System FDA UDI
- Generic Name
- Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Sm Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm 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
- 2Z2831G FDA UDI
- Description
- The ZEUS ELISA Sm Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to Sm 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
- 2Z2831G FDA UDI
- Primary DI / UDI-DI
- 00845533001076 FDA UDI
- GMDN Term
- Smith antibody (anti-Sm) 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: Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA)
ELISA Sm Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 16919f7c-a8dc-4888-a1e9-234bce886eb3 35 fields · synced May 30, 2026