Identity
- Trade Name
- ADVIA® Chemistry IGM_2 Reagents FDA UDI
- Generic Name
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
- Device Name
- IgM - ADVIA Chem. - RGT - 4x90 tests FDA UDI
- Model / Reference
- 10309032 FDA UDI
- Description
- IgM - ADVIA Chem. - RGT - 4x90 tests FDA UDI
Identifiers
- Catalog Number
- 2193483 FDA UDI
- Primary DI / UDI-DI
- 00630414513126 FDA UDI
- 510(k) Number
- K992662 FDA UDI
- FDA Product Code
- CFN FDA UDI
- GMDN Term
- Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.5510 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: Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
ADVIA® Chemistry IGM_2 Reagents by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry.
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- N Latex IgM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Alinity — Abbott · Class II
- Alinity — ABBOTT IRELAND · Class II
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Cleared under the same submission
K992662 also covers:
- ADVIA® Chemistry APO A1 Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry APO B Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry IGA_2 Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry IGG_2 Reagents — Siemens Healthcare Diagnostics
- ADVIA® Chemistry TRF Transferrin Reagents — Siemens Healthcare Diagnostics
- Atellica CH APO A1 — Siemens Healthcare Diagnostics
- Atellica CH APO B — Siemens Healthcare Diagnostics
- Atellica CH IgA_2 — Siemens Healthcare Diagnostics
- Atellica CH IgG_2 — Siemens Healthcare Diagnostics
- Atellica CH IgM_2 — Siemens Healthcare Diagnostics
- Atellica CH Trf — Siemens Healthcare Diagnostics
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 c961d10a-e4de-4af7-a77b-408ed5ef9a64 37 fields · synced Jun 8, 2026