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ImmunoFA Toxoplasma IgM Positive Control
FDA UDIClass II (US FDA UDI)
by Genbio
Identity
- Trade Name
- ImmunoFA Toxoplasma IgM Positive Control FDA UDI
- Generic Name
- Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, control FDA UDI
- Device Name
- Positive control for use with ImmunoFA Toxoplasma IgM kit. FDA UDI
- Model / Reference
- 800-1341 FDA UDI
- Description
- Positive control for use with ImmunoFA Toxoplasma IgM kit. FDA UDI
Identifiers
- Catalog Number
- 1341 FDA UDI
- Primary DI / UDI-DI
- 00613745013411 FDA UDI
- 510(k) Number
- K803134 FDA UDI
- FDA Product Code
- GLZ FDA UDI
- GMDN Term
- Toxoplasma gondii immunoglobulin M (IgM) 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 IgM Positive 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 |
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Manufacturer
- Manufacturer
- Genbio
Sources (1)
- FDA UDI 859bd0dc-f8b1-423b-a615-693644c7f568 39 fields · synced Jun 8, 2026