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IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG FDA UDI
- Generic Name
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Rubella IgG Ab - IMMULITE - RGT - 100 Tests FDA UDI
- Model / Reference
- 10381292 FDA UDI
- Description
- Rubella IgG Ab - IMMULITE - RGT - 100 Tests FDA UDI
Identifiers
- Catalog Number
- LKRUB1 FDA UDI
- Primary DI / UDI-DI
- 00630414964614 FDA UDI
- 510(k) Number
- K963613 FDA UDI
- FDA Product Code
- LFX FDA UDI
- GMDN Term
- Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay 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
No
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, chemiluminescent immunoassay
IMMULITE®/IMMULITE® 1000 Systems RUB Rubella Quantitative IgG by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Rubella virus immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay.
- ADVIA Centaur® Rub G — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- LIAISON® Rubella IgG — Diasorin Inc.
- Atellica IM Rub G — Siemens Healthcare Diagnostics · Class II
- VITROS — Ortho-Clinical Diagnostics · Class II
- IMMULITE® 2000 Systems RUB Rubella Quantitative IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- IMMULITE® 2000 Systems RUB Rubella Quantitative IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
Cleared under the same submission
K963613 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
- Siemens Healthcare Diagnostics Products Ltd
Sources (1)
- FDA UDI 69ff69be-ba9c-4c33-a043-785d3c493466 37 fields · synced May 30, 2026