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FilmArray® Meningitis/Encephalitis (ME) Panel

FDA UDI

Class II (US FDA UDI)

by BioFire Diagnostics, LLC

Identity

Trade Name
FilmArray® Meningitis/Encephalitis (ME) Panel FDA UDI
Generic Name
Multiple-type meningitis 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-0119 FDA UDI
Description
IVD reagent kit containing 6 tests. FDA UDI

Identifiers

Catalog Number
RFIT-ASY-0119 FDA UDI
Primary DI / UDI-DI
00815381020130 FDA UDI
510(k) Number
DEN150013 FDA UDI
K160462 FDA UDI
FDA Product Code
PLO FDA UDI
GMDN Term
Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT) FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3970 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 meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)

FilmArray® Meningitis/Encephalitis (ME) Panel by BioFire Diagnostics, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type meningitis pathogen nucleic acid IVD, kit, nucleic acid technique (NAT).

Cleared under the same submission

DEN150013 also covers:

K160462 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 b8e67541-affd-4aa0-8841-4eb027a63894 35 fields · synced Jun 9, 2026