Identity
- Trade Name
- Fort Worth Diagnostics FDA UDI
- Generic Name
- Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, control FDA UDI
- Device Name
- Influenza A H5N1 Control 1E5 cp/mL FDA UDI
- Model / Reference
- H5N1POS FDA UDI
- Description
- Influenza A H5N1 Control 1E5 cp/mL FDA UDI
Identifiers
- Catalog Number
- H5N1POS FDA UDI
- Primary DI / UDI-DI
- 00850051429653 FDA UDI
- FDA Product Code
- JJX FDA UDI
- GMDN Term
- Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, control FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.1660 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, control
Fort Worth Diagnostics by Fort Worth Diagnostics Llc — Class I — 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 I | Pending data |
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Manufacturer
- Manufacturer
- Fort Worth Diagnostics Llc
Sources (1)
- FDA UDI 67600c52-18a0-4a75-a457-8ce2c1af44c5 36 fields · synced May 30, 2026