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FilmArray Pneumonia/Pneumoniaplus Control

FDA UDI

Class II (US FDA UDI)

by Mmqci

Identity

Trade Name
FilmArray Pneumonia/Pneumoniaplus Control FDA UDI
Generic Name
Multiple-type respiratory pathogen nucleic acid IVD, control FDA UDI
Device Name
External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray Pneumonia Panel or Pneumonia Panel plus assay on the FilmArray systems. FDA UDI
Model / Reference
v.00 FDA UDI
Description
External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray Pneumonia Panel or Pneumonia Panel plus assay on the FilmArray systems. FDA UDI

Identifiers

Catalog Number
M340 FDA UDI
Primary DI / UDI-DI
00852720008022 FDA UDI
FDA Product Code
PMN FDA UDI
GMDN Term
Multiple-type respiratory pathogen nucleic acid IVD, control FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
866.3920 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

No

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 respiratory pathogen nucleic acid IVD, control

FilmArray Pneumonia/Pneumoniaplus Control by Mmqci — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Multiple-type respiratory pathogen nucleic acid IVD, control.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Mmqci

Sources (1)

  • FDA UDI 41f08d39-2bc1-4ca3-8c73-49ab86c8259d 35 fields · synced May 30, 2026