Duns Number:119234263
Device Description: QIAGEN EZ1 Advanced XL Instrument for use with Acuitas AMR Gene Panel.
Catalog Number
AC043
Brand Name
Acuitas
Version/Model Number
AC043
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 25, 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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K191288
Product Code
JJH
Product Code Name
Clinical Sample Concentrator
Public Device Record Key
8f440cd6-32ff-4710-8727-a9090411c8e4
Public Version Date
September 16, 2022
Public Version Number
3
DI Record Publish Date
October 25, 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 8 |