Identity
- Trade Name
- ImmunoFA Toxoplasma IgG Low Control FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, control FDA UDI
- Device Name
- Positive Control for use with ImmunoFA Toxoplasma IgG kit. FDA UDI
- Model / Reference
- 800-1204 FDA UDI
- Description
- Positive Control for use with ImmunoFA Toxoplasma IgG kit. FDA UDI
Identifiers
- Catalog Number
- 1204 FDA UDI
- Primary DI / UDI-DI
- 00613745012049 FDA UDI
- 510(k) Number
- K803134 FDA UDI
- FDA Product Code
- GLZ 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
- Not 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
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
ImmunoFA Toxoplasma IgG Low Control by Genbio — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Genbio
Sources (1)
- FDA UDI 42df48eb-e9c6-44ab-9f98-4a2188ee3536 39 fields · synced Jun 6, 2026