Duns Number:556915205
Device Description: FilmArray® NGDS Warrior Panel - IVD reagent Biothreat Detection Kit containing 30 tests.
Catalog Number
NGDS-ASY-0006
Brand Name
NGDS
Version/Model Number
NGDS-ASY-0006
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
February 01, 2018
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
NSU
Product Code Name
Instrumentation For Clinical Multiplex Test Systems
Public Device Record Key
8563833f-b6ca-462b-b964-293ef0e2aa07
Public Version Date
April 05, 2022
Public Version Number
5
DI Record Publish Date
April 21, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 14 |
| U | Unclassified | 1 |