Identity
- Trade Name
- LIAISON® Toxo IgM II FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Model / Reference
- 310715 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056771100809 FDA UDI
- GMDN Term
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
Classification
- 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
Yes
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
LIAISON® Toxo IgM II by Diasorin Inc. — 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
- IMMULITE® 2000 Systems TXM Toxoplasma IgM — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Atellica IM Toxo M — Siemens Healthcare Diagnostics · Class II
- Elecsys Toxo IgM — Roche Diagnostics Corp. · Class II
- ADVIA Centaur® Toxo M — Siemens Healthcare Diagnostics · Class II
- Elecsys Toxo IgM — Roche Diagnostics Corp. · Class II
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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Diasorin Inc.
Sources (1)
- FDA UDI 52cda3a8-3995-45ad-85e7-4701b322bcde 33 fields · synced May 30, 2026