Identity
- Trade Name
- BIOFIRE ® SPOTFIRE ® Module FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- Used IVD Instrument (SPOTFIRE® Module). FDA UDI
- Model / Reference
- FAST-ASY-0002-W FDA UDI
- Description
- Used IVD Instrument (SPOTFIRE® Module). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815381020376 FDA UDI
- 510(k) Number
- K213954 FDA UDI
- FDA Product Code
- NSU FDA UDI
- GMDN Term
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 862.2570 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
Yes
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thermal cycler nucleic acid amplification analyser IVD, laboratory
BIOFIRE ® SPOTFIRE ® Module by BioFire Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 669a1a0e-6f36-472f-b593-a4442708f070 34 fields · synced Jun 9, 2026