← Back to catalogue
ImmunoFA Toxoplasma IgG Negative Control
FDA UDIClass II (US FDA UDI)
by Genbio
Identity
- Trade Name
- ImmunoFA Toxoplasma IgG Negative Control FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent FDA UDI
- Device Name
- Negative control for use with ImmunoFA Toxoplasma kits. FDA UDI
- Model / Reference
- 800-1203 FDA UDI
- Description
- Negative control for use with ImmunoFA Toxoplasma kits. FDA UDI
Identifiers
- Catalog Number
- 1203 FDA UDI
- Primary DI / UDI-DI
- 00613745012032 FDA UDI
- 510(k) Number
- K803134 FDA UDI
- FDA Product Code
- GLZ FDA UDI
- GMDN Term
- Toxoplasma gondii immunoglobulin G (IgG)/IgM antibody IVD, reagent 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 Negative 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 7bdac262-ffea-468b-978d-fc73e1c12b84 39 fields · synced May 31, 2026