FilmArray Warrior Control Panel M290 - External quality controls to monitor the - Mmqci

Duns Number:172874245

Device Description: External quality controls to monitor the performance of in vitro laboratory nucleic acid t External quality controls to monitor the performance of in vitro laboratory nucleic acid testing procedures for the FilmArray® NGDS Warrior Panel performed on FilmArray systems.

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More Product Details

Catalog Number

M290

Brand Name

FilmArray Warrior Control Panel M290

Version/Model Number

v.00

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K163522

Product Code Details

Product Code

PMN

Product Code Name

Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Device Record Status

Public Device Record Key

a28ead52-bbe6-4daa-adf6-91fdef236059

Public Version Date

December 21, 2020

Public Version Number

2

DI Record Publish Date

November 24, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MMQCI" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 10