Identity
- Trade Name
- BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel FDA UDI
- Generic Name
- Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
- Device Name
- IVD reagent kit containing 30 tests. FDA UDI
- Model / Reference
- 424461 FDA UDI
- Description
- IVD reagent kit containing 30 tests. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815381020659 FDA UDI
- 510(k) Number
- K213954 FDA UDI
- FDA Product Code
- QOF FDA UDIOCC FDA UDIOEM FDA UDIOOU FDA UDIOTG FDA UDIOZE FDA UDIOZX FDA UDIOZY FDA UDIOZZ FDA UDI
- GMDN Term
- Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 866.3981 FDA UDI866.3980 FDA UDI
- Commercial Distribution
- 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
Category: Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
BIOFIRE ® SPOTFIRE ® Respiratory (R) Panel by BioFire Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).
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- BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini — BioFire Diagnostics, LLC · Class II
Cleared under the same submission
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
- BioFire Diagnostics, LLC
Sources (1)
- FDA UDI 9f8f7f0c-d700-4aa7-802e-7270e4be47d3 34 fields · synced Jun 9, 2026