Identity
- Trade Name
- QMedix™ FDA UDI
- Generic Name
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- QMedix™ Rubella IgG ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
- Model / Reference
- DACD1301-1 FDA UDI
- Description
- QMedix™ Rubella IgG ELISA This test is intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Rubella virus in a clinical specimen, using an enzyme immunoassay (EIA) method. FDA UDI
Identifiers
- Catalog Number
- 1301-1 FDA UDI
- Primary DI / UDI-DI
- 00850054026019 FDA UDI
- FDA Product Code
- OPL FDA UDI
- GMDN Term
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3510 FDA UDI
- 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
No
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 G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)
QMedix™ by Diagnostic Automation, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA).
- BioSign® Rubella card — PRINCETON BIOMEDITECH CORP. · Class II
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- Elecsys Rubella IgG — Roche Diagnostics Corp. · Class II
- ELISA Rubella IgG Smart Kit Test System — ZEUS SCIENTIFIC, INC.
- SeraQuest — QUEST INTERNATIONAL, INC. · Class II
- VIDAS® RUB IgG — BIOMERIEUX , INC. · Class II
- Trinity Biotech — CLARK LABORATORIES, 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Diagnostic Automation, Inc.
Sources (1)
- FDA UDI 18af67f3-a6f7-448c-9d39-d52c8545268b 37 fields · synced May 30, 2026