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.
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
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
PMN
Product Code Name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |