Identity
- Trade Name
- ADVIA Centaur® Toxo M FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Toxoplasma IgM Ab - CENTAUR - RGT - 50 tests FDA UDI
- Model / Reference
- 10310320 FDA UDI
- Description
- Toxoplasma IgM Ab - CENTAUR - RGT - 50 tests FDA UDI
Identifiers
- Catalog Number
- 120153 FDA UDI
- Primary DI / UDI-DI
- 00630414208442 FDA UDI
- 510(k) Number
- K010755 FDA UDI
- FDA Product Code
- LGD FDA UDI
- GMDN Term
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3780 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: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay
ADVIA Centaur® Toxo M by Siemens Healthcare Diagnostics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay.
- Alinity — Abbott · Class II
- Elecsys Toxo IgM — Roche Diagnostics Corp. · Class II
- Alinity — Abbott · Class II
- LIAISON® Toxo IgM II — Diasorin Inc.
- IMMULITE® 2000 Systems TXM Toxoplasma IgM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Elecsys Toxo IgM — Roche Diagnostics Corp. · Class II
- Elecsys Toxo IgM — Roche Diagnostics Corp. · Class II
- Atellica IM Toxo M — 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 27c8d290-e888-443d-af45-51f5a44fe50a 37 fields · synced Jun 8, 2026