Identity
- Trade Name
- VIDAS® TOXO IgG II FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- TOXO IgG II (TXG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of anti - toxoplasma IgG concentration in human serum or plasma. FDA UDI
- Model / Reference
- 30210-01 FDA UDI
- Description
- TOXO IgG II (TXG) assay is a quantitative IA intended for use on VIDAS family instrument in the detection of anti - toxoplasma IgG concentration in human serum or plasma. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03573026156855 FDA UDI
- 510(k) Number
- K993319 FDA UDI
- FDA Product Code
- LGD FDA UDI
- GMDN Term
- Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) 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, enzyme immunoassay (EIA)
VIDAS® TOXO IgG II by Biomerieux , Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Biomerieux , Inc.
Sources (1)
- FDA UDI c6ae2b81-d23a-4c0f-92ef-966947c42fa2 35 fields · synced Jun 8, 2026