Duns Number:119234263
Device Description: Labeled, OpGen branded flash drive containing IVD Acuitas AMR Gene Analysis Software.
Catalog Number
CP3511
Brand Name
Acuitas
Version/Model Number
CP3511
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
PMY
Product Code Name
System, Nucleic Acid Amplification Test, Dna, Carbapenem Non-Susceptible Gram Negative Organism, Colony
Public Device Record Key
fec23a59-646c-4ec1-9d4e-77359cb30420
Public Version Date
March 28, 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 |