Identity
- Trade Name
- ASI Rubella IgG EIA Test FDA UDI
- Generic Name
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- Detection of Rubella Virus Antiboby FDA UDI
- Model / Reference
- NC-800096-AG FDA UDI
- Description
- Detection of Rubella Virus Antiboby FDA UDI
Identifiers
- Catalog Number
- NC-800096-AG FDA UDI
- Primary DI / UDI-DI
- 00816057020515 FDA UDI
- 510(k) Number
- K961053 FDA UDI
- FDA Product Code
- LFX 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
No
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)
ASI Rubella IgG EIA Test by Arlington Scientific, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
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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- ELISA Rubella IgG Q Test System — ZEUS SCIENTIFIC, INC.
- 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
Cleared under the same submission
K961053 also covers:
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
- Arlington Scientific, Inc.
Sources (1)
- FDA UDI 3b547f9e-698e-4583-a906-d1e8d46a7935 38 fields · synced Jul 18, 2026