Identity
- Trade Name
- Alinity FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay FDA UDI
- Device Name
- Alinity i Toxo IgG Reagent Kit (1000T) FDA UDI
- Model / Reference
- 07P4545 FDA UDI
- Description
- Alinity i Toxo IgG Reagent Kit (1000T) FDA UDI
Identifiers
- Catalog Number
- 07P4545 FDA UDI
- Primary DI / UDI-DI
- 00380740174361 FDA UDI
- 510(k) Number
- K210596 FDA UDI
- FDA Product Code
- LGD FDA UDI
- GMDN Term
- Toxoplasma gondii immunoglobulin G (IgG) 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
Yes
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 G (IgG) antibody IVD, kit, chemiluminescent immunoassay
Alinity by Abbott — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, chemiluminescent immunoassay.
- Elecsys Toxo IgG — Roche Diagnostics Corp. · Class II
- IMMULITE®/IMMULITE® 1000 Systems TXP Toxoplasma Quantitative IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- Atellica IM Toxo G — Siemens Healthcare Diagnostics · Class II
- IMMULITE® 2000 Systems TXP Toxoplasma Quantitatve IgG — SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD · Class II
- ADVIA Centaur® Toxo G — Siemens Healthcare Diagnostics · Class II
- LIAISON® Toxo IgG II — Diasorin Inc.
- Elecsys Toxo IgG Immunoassay — Roche Diagnostics Corp. · Class II
- Alinity — Abbott · 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
- Abbott
Sources (1)
- FDA UDI 6c3ab952-ad9d-4008-91a4-c4498984cdfd 37 fields · synced May 30, 2026