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FilmArray® 2.0 Instrument

FDA UDI

Class II (US FDA UDI)

by BioFire Diagnostics, LLC

Identity

Trade Name
FilmArray® 2.0 Instrument FDA UDI
Generic Name
Thermal cycler nucleic acid amplification analyser IVD, laboratory FDA UDI
Device Name
Refurbished IVD Instrument (FilmArray® 2.0 Instrument). FDA UDI
Model / Reference
FLM2-ASY-0001 FDA UDI
Description
Refurbished IVD Instrument (FilmArray® 2.0 Instrument). FDA UDI

Identifiers

Catalog Number
FLM2-ASY-0001R FDA UDI
Primary DI / UDI-DI
00815381020048 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
Not 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

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

FilmArray® 2.0 Instrument by BioFire Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K143178 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
BioFire Diagnostics, LLC

Sources (1)

  • FDA UDI a87a374f-cf95-4996-9951-b5bd58dc277e 36 fields · synced Jun 9, 2026