Identity
- Trade Name
- Atellica IM Rub G QC FDA UDI
- Generic Name
- Rubella virus immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- Rubella IgG (Rub G) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL FDA UDI
- Model / Reference
- 10995671 FDA UDI
- Description
- Rubella IgG (Rub G) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL FDA UDI
Identifiers
- Catalog Number
- 10995671 FDA UDI
- Primary DI / UDI-DI
- 00630414600536 FDA UDI
- 510(k) Number
- K003412 FDA UDI
- FDA Product Code
- LFX FDA UDI
- GMDN Term
- Rubella virus immunoglobulin G (IgG) antibody IVD, control 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
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, control
Atellica IM Rub G QC by Siemens Healthcare Diagnostics — Class II — IVDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Rubella virus immunoglobulin G (IgG) antibody IVD, control.
- PreciControl Rubella IgG — Roche Diagnostics Corp. · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class II
- IMMULITE Systems Rubella Quantitative IgG CVM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class I
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- LIAISON® Rubella IgG TRI-Controls — Diasorin Inc.
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class I
Cleared under the same submission
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Siemens Healthcare Diagnostics
Sources (2)
- FDA UDI e557d566-baa2-46c2-aaea-5e749128dbb6 37 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026