Duns Number:079280262
Device Description: Refurbished IVD Instrument (FilmArray® 2.0 Instrument).
Catalog Number
FLM2-ASY-0001R
Brand Name
FilmArray® 2.0 Instrument
Version/Model Number
FLM2-ASY-0001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 21, 2021
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K143178
Product Code
NSU
Product Code Name
Instrumentation For Clinical Multiplex Test Systems
Public Device Record Key
a87a374f-cf95-4996-9951-b5bd58dc277e
Public Version Date
September 16, 2022
Public Version Number
6
DI Record Publish Date
September 23, 2016
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. | 31 |