Identity
- Trade Name
- ELISA Rubella IgM Test System FDA UDI
- Generic Name
- Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Rubella IgM Test System is designed for the qualitative detection of IgM antibodies to the rubella virus in human serum. The assay is intended to be used to evaluate serologic evidence of active or recent infection with rubella virus, and is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- 9Z9801M FDA UDI
- Description
- The ZEUS ELISA Rubella IgM Test System is designed for the qualitative detection of IgM antibodies to the rubella virus in human serum. The assay is intended to be used to evaluate serologic evidence of active or recent infection with rubella virus, and is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 9Z9801M FDA UDI
- Primary DI / UDI-DI
- 00845533001038 FDA UDI
- GMDN Term
- Rubella virus immunoglobulin M (IgM) 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: Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
ELISA Rubella IgM Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA).
- Rubella IgM AccuBind ELISA Test System - 96 Wells — MONOBIND, INC. · Class II
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- Pointe Scientific, Inc. Rubella IgM — POINTE SCIENTIFIC, INC. · Class II
- Rubella IgM AccuBind ELISA Test System - 192 Wells — MONOBIND, INC. · Class II
- Bio-Rad Laboratories, Inc. — Bio-Rad Laboratories · Class II
- Trinity Biotech — CLARK LABORATORIES, INC. · Class II
- ASI Rubella IgM EIA Test — Arlington Scientific, Inc. · Class II
- ReQuest — 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 9f4fbab1-4fb8-4518-a511-efd390961612 35 fields · synced May 31, 2026