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FilmArray® Respiratory Panel 2 (RP2)

FDA UDI

Class II (US FDA UDI)

by BioFire Diagnostics, LLC

Identity

Trade Name
FilmArray® Respiratory Panel 2 (RP2) FDA UDI
Generic Name
Multiple-type respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI
Device Name
IVD reagent kit containing 6 tests FDA UDI
Model / Reference
RFIT-ASY-0130 FDA UDI
Description
IVD reagent kit containing 6 tests FDA UDI

Identifiers

Catalog Number
RFIT-ASY-0130 FDA UDI
Primary DI / UDI-DI
00815381020161 FDA UDI
FDA Product Code
OZZ FDA UDI
OZY FDA UDI
OZX FDA UDI
OTG FDA UDI
OOU FDA UDI
OEP FDA UDI
OEM FDA UDI
OCC 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
866.3980 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

FilmArray® Respiratory Panel 2 (RP2) by BioFire Diagnostics, 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

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Manufacturer

Manufacturer
BioFire Diagnostics, LLC

Sources (1)

  • FDA UDI 274c8e71-d3b2-4bb5-8469-50b7d089d26e 35 fields · synced Jun 9, 2026