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 RP EZ assay on the FilmArray systems.
Catalog Number
M265
Brand Name
FilmArray RP EZ Control Panel M265
Version/Model Number
v.00
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2022
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
-
Product Code
PMN
Product Code Name
Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays
Public Device Record Key
011019aa-3edf-4fae-86fb-2ec924ee8ebd
Public Version Date
June 14, 2022
Public Version Number
2
DI Record Publish Date
January 22, 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 |