Identity
- Trade Name
- FilmArray® 2.0 Instrument NGDS Configuration FDA UDI
- Generic Name
- Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
- Device Name
- NGDS FilmArray Configuration kit (no computer included). FDA UDI
- Model / Reference
- NGDS-ASY-0004 FDA UDI
- Description
- NGDS FilmArray Configuration kit (no computer included). FDA UDI
Identifiers
- Catalog Number
- NGDS-ASY-0004 FDA UDI
- Primary DI / UDI-DI
- 00851458005143 FDA UDI
- 510(k) Number
- K143178 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
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
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
FilmArray® 2.0 Instrument NGDS Configuration by BioFire Defense, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K143178 also covers:
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 db6fc9a4-57fa-436f-a837-5fa9cb5a5e70 36 fields · synced May 29, 2026