Identity
- Trade Name
- ELISA SSB (La) Test System FDA UDI
- Generic Name
- SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA SSB (La) Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to SSB 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
- 2Z2821G FDA UDI
- Description
- The ZEUS ELISA SSB (La) Test System is a semi-quantitative immunoassay for the detection of IgG antibodies to SSB 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
- 2Z2821G FDA UDI
- Primary DI / UDI-DI
- 00845533001137 FDA UDI
- GMDN Term
- SSB/La antibody (Sjogren's 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: SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
ELISA SSB (La) Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA).
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- Gold Standard Diagnostics Is-anti-SS-B ELISA Test Kit — Gold Standard Diagnostics, LLC · Class II
- QUANTA Lite® SS-B ELISA — INOVA DIAGNOSTICS, INC. · Class II
- ReQuest — QUEST INTERNATIONAL, INC. · Class II
- AESKULISA® SS-B — Aesku.Diagnostics GmbH & Co. KG · 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 5ec9caee-e0d1-4224-8cb6-13abeca151d2 35 fields · synced Jun 8, 2026