Identity
- Trade Name
- AccuDiag ™ FDA UDI
- Generic Name
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- AccuDiag ™ Rubella IgG ELISA is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use. FDA UDI
- Model / Reference
- DACD 1301-2 FDA UDI
- Description
- AccuDiag ™ Rubella IgG ELISA is designed for the qualitative and/or quantitative detection of IgG antibodies to rubella virus in human serum. This test is intended to be used to evaluate single sera for immune status or paired sera to demonstrate seroconversion, and is for In Vitro diagnostic use. FDA UDI
Identifiers
- Catalog Number
- 1301-2 FDA UDI
- Primary DI / UDI-DI
- 00894175000039 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)
AccuDiag ™ 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).
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- 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 d9d8bf1e-708c-4b97-ae2c-d298c859fe07 37 fields · synced May 30, 2026