Identity
- Trade Name
- Atellica IM Rub M QC FDA UDI
- Generic Name
- Rubella virus immunoglobulin M (IgM) antibody IVD, control FDA UDI
- Device Name
- Rubella IgM (Rub M) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL FDA UDI
- Model / Reference
- 10995669 FDA UDI
- Description
- Rubella IgM (Rub M) QC Kit Atellica IM - CLT 3 x 2 x 5.0mL FDA UDI
Identifiers
- Catalog Number
- 10995669 FDA UDI
- Primary DI / UDI-DI
- 00630414599847 FDA UDI
- 510(k) Number
- K010668 FDA UDI
- FDA Product Code
- LFX FDA UDI
- GMDN Term
- Rubella virus immunoglobulin M (IgM) 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 M (IgM) antibody IVD, control
Atellica IM Rub M QC by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rubella virus immunoglobulin M (IgM) antibody IVD, control.
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- IMMULITE® Systems RUM CONTROL Rubella IgM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- PreciControl Rubella IgM — Roche Diagnostics Corp. · Class I
- LIAISON® Control Rubella IgM — Diasorin Inc.
- PreciControl Rubella IgM — Roche Diagnostics Corp. · Class I
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- ADVIA Centaur® Rub M QC — Siemens Healthcare Diagnostics · Class II
Cleared under the same submission
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
Sources (1)
- FDA UDI afc85560-8ffb-401c-91bb-43a3c2722966 37 fields · synced Jun 1, 2026