Identity
- Trade Name
- JBAIDS FDA UDI
- Generic Name
- Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- JBAIDS IVD Influenza A/H5 Detection Kit FDA UDI
- Model / Reference
- JRPD-ASY-0136 FDA UDI
- Description
- JBAIDS IVD Influenza A/H5 Detection Kit FDA UDI
Identifiers
- Catalog Number
- JRPD-ASY-0136 FDA UDI
- Primary DI / UDI-DI
- 00851458005082 FDA UDI
- FDA Product Code
- NXD FDA UDI
- GMDN Term
- Influenza A virus H5N1 subtype (avian influenza) nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3332 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
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
Jbaids by BioFire Defense, LLC — 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
- BioFire Defense, LLC
Sources (1)
- FDA UDI 91edb688-0e59-4f63-a350-b8d0df9977ec 36 fields · synced May 29, 2026