Identity
- Trade Name
- IMMULITE® Systems TXP CONTROL Toxoplasma IgG FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- Toxoplasma IGG - IMMULITE - CTL FDA UDI
- Model / Reference
- 10469600 FDA UDI
- Description
- Toxoplasma IGG - IMMULITE - CTL FDA UDI
Identifiers
- Catalog Number
- LTXPCM FDA UDI
- Primary DI / UDI-DI
- 00630414976747 FDA UDI
- 510(k) Number
- K962936 FDA UDI
- FDA Product Code
- LGD FDA UDI
- GMDN Term
- Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control 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
Yes
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 G (IgG) antibody IVD, control
IMMULITE® Systems TXP CONTROL Toxoplasma IgG by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control.
- PreciControl Toxo IgG — Roche Diagnostics Corp. · Class I
- ADVIA Centaur® Toxo G QC — Siemens Healthcare Diagnostics · Class II
- Validate — LGC Clinical Diagnostics, Inc. · Class I
- Alinity — Abbott · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- Atellica IM Toxo G QC — Siemens Healthcare Diagnostics · Class II
- BioPlex 2200 — Bio-Rad Laboratories · Class I
- LIAISON® Control Toxo IgG II — Diasorin Inc.
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 Products Ltd
Sources (1)
- FDA UDI b67832d3-1970-4695-bd70-5d930c55d2a1 37 fields · synced May 30, 2026