Identity
- Trade Name
- ELISA Mumps IgG Bulk Test System FDA UDI
- Generic Name
- Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- The ZEUS ELISA Mumps IgG Test System is intended for the qualitative detection of Mumps IgG antibody in human sera. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of Mumps infections. FDA UDI
- Model / Reference
- 9Z9281GB FDA UDI
- Description
- The ZEUS ELISA Mumps IgG Test System is intended for the qualitative detection of Mumps IgG antibody in human sera. When performed according to these instructions, the results of this test, together with other clinical information, may aid in the determination of immune status, and/or aid in the diagnosis of Mumps infections. FDA UDI
Identifiers
- Catalog Number
- 9Z9281GB FDA UDI
- Primary DI / UDI-DI
- 00845533000871 FDA UDI
- GMDN Term
- Mumps virus immunoglobulin G (IgG) 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: Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
ELISA Mumps IgG Bulk Test System by Zeus Scientific, Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
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- SeraQuest — QUEST INTERNATIONAL, INC. · Class I
- ASI Mumps IgG EIA Test — Arlington Scientific, Inc. · Class I
- Trinity Biotech — CLARK LABORATORIES, INC. · Class I
- CHORUS MUMPS IgG — DIESSE DIAGNOSTICA SENESE SPA · Class I
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 bd386606-2981-4b6d-86c3-2e7a7702488d 35 fields · synced May 30, 2026