Duns Number:119234263
Device Description: QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Pane QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel.
Catalog Number
AC042
Brand Name
Acuitas
Version/Model Number
AC042
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
OOI
Product Code Name
Real Time Nucleic Acid Amplification System
Public Device Record Key
1c9b1c3e-c3d3-42d7-891f-e919a407bdb8
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 |