Duns Number:107186004
Device Description: ACQUITY UPLC BEH C18 1.7 µm 2.1x50mmIVD
Catalog Number
186002350IVD
Brand Name
Acquity
Version/Model Number
186002350IVD
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
-
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
DPM
Product Code Name
Columns, Liquid Chromatography
Public Device Record Key
148e2f7f-cce8-43a3-86e0-6c55729a32d8
Public Version Date
October 13, 2021
Public Version Number
1
DI Record Publish Date
October 05, 2021
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 | 28 |
2 | A medical device with a moderate to high risk that requires special controls. | 3 |